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The Effects of a Novel Therapeutic Intervention in Diabetic Peripheral Neuropathy Patients

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Objective: To determine the effect of a novel therapeutic intervention called intraneural facilitation (INF) on balance measures and a neuropathy scale in patients with diabetic peripheral neuropathy. Design: Prospective pre- and post-test, single group clinical trial. Setting: Outpatient physical therapy clinic. Participants: Thirteen patients with diabetic peripheral neuropathy. Intervention: Subjects received ten sessions of INF. Main outcome measures: The modified total neuropathy scale (mTNS), the NeuroCom(®) Smart Balance Master system computerized dynamic posturography (CDP) that includes the sensory organization test (SOT) and the limits of stability (LOS), and the activities-specific balance and confidence (ABC) scale. Results: Subjects in this study showed significant improvement in the mTNS, SOT, and one component in the LOS (movement velocity, MVL). There were no significant differences in the ABC or in 4 components of the LOS, which were reaction time (RT), endpoint excursion (EPE), maximum excursion (MXE), and directional control (DCL). Conclusion: Intraneural facilitation improved objective balance measures and neuropathy symptoms in patients with diabetic peripheral neuropathy. Further study is needed to determine long-term benefits of this intervention.
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ORIGINAL RESEARCH
Effects of a Novel Therapeutic Intervention in
Patients With Diabetic Peripheral Neuropathy
Adel Alshahrani, DSc,
a
Mark Bussell, DPT,
b
Eric Johnson, DSc,
a
Bryan Tsao, MD,
c
Khalid Bahjri, MD
d
From the
a
School of Allied Health Professions, Department of Physical Therapy, Loma Linda University, Loma Linda, CA;
b
East Campus
Rehabilitation Services, Department of Physical Therapy, Loma Linda University Medical Center, Loma Linda, CA;
c
Clinical Neurophysiology,
Neurology Department, Loma Linda University School of Medicine, Loma Linda, CA;
d
School of Public Health, Department of Public Health,
Loma Linda University, Loma Linda, CA.
Abstract
Objective: To determine the effect of a novel therapeutic intervention called intraneural facilitation on balance measures and a neuropathy scale
in patients with diabetic peripheral neuropathy.
Design: Prospective pre- and posttest, single group clinical trial.
Setting: Outpatient physical therapy clinic.
Participants: Patients with diabetic peripheral neuropathy (NZ13).
Intervention: Subjects received 10 sessions of intraneural facilitation.
Main Outcome Measures: The modified Total Neuropathy Scale, the NeuroCom SMART Balance Master system computerized dynamic
posturography (CDP) that includes the Sensory Organization Test (SOT) and the limits of stability (LOS), and the Activities-specific Balance and
Confidence (ABC) scale.
Results: Subjects in this study showed significant improvement in the modified Total Neuropathy Scale, SOT, and 1 component in the LOS test
(movement velocity). There were no significant differences in the ABC scale or in 4 components of the LOS test, which were reaction time, end
point excursion, maximum excursion, and directional control.
Conclusions: Intraneural facilitation improved objective balance measures and neuropathy symptoms in patients with diabetic peripheral
neuropathy. Further study is needed to determine long-term benefits of this intervention.
Archives of Physical Medicine and Rehabilitation 2016;-:-------
ª2016 by the American Congress of Rehabilitation Medicine
Diabetes mellitus (DM) is a common disorder affecting in-
dividuals in the United States and in the world.
1
The prevalence of
DM has increased noticeably over the last 3 decades with an
estimated 380 million people currently diagnosed with the dis-
ease.
1
DM is associated with numerous systemic complications
that effect the retina, heart, brain, kidneys, and nerves.
2,3
The most common symptomatic complication of DM is dia-
betic peripheral neuropathy (DPN), estimated to occur in 50% of
patients with DM.
4
Despite therapeutic advances of diabetes care
over the last decade, there are few known interventions that
appropriately address the progression and treatment of DPN.
5
DPN
can occur in many forms, but it most commonly presents as a
painless sensorimotor distal symmetric polyneuropathy (DSPN).
2
Diabetic DSPN causes deterioration of the peripheral nervous
system in a length-dependent fashion and can negatively affect the
sensory system.
6,7
Impaired proprioceptive input renders these
patients more susceptible to loss of balance during static and
dynamic conditions.
7-12
This can impair physical function by
reducing standing and walking activities because many patient
experience fear of falling.
13,14
The pathogenesis of DPN is multifactorial and mediated by
alterations in the polyol pathway, aldose reductase inhibitors,
advanced glycation products, disordered biochemistry conse-
quences, essential fatty acids, neurotrophic factors, and oxidative
stress. The common pathologic end point is endoneurial micro-
angiopathy and subsequent nerve ischemia and hypoxia.
15,16
As
such, patients with DPN are more likely to develop an array of
peripheral nerve disorders and balance problems and are at a
higher risk of falling.
9-12,15,17-22
Disclosures: none.
0003-9993/16/$36 - see front matter ª2016 by the American Congress of Rehabilitation Medicine
http://dx.doi.org/10.1016/j.apmr.2015.12.026
Archives of Physical Medicine and Rehabilitation
journal homepage: www.archives-pmr.org
Archives of Physical Medicine and Rehabilitation 2016;-:-------
The current study used an innovative approach termed intra-
neural facilitation in the treatment of diabetic DSPN. This
approach aims to bias blood flow into the neural fascicle, improve
endoneurial capillary circulation, and reverse intrafascicular
ischemia. This passive technique includes stretching muscles,
mobilizing joints, tractioning skin, distending visceral structures,
and distorting blood vessels to reroute blood to the ischemic
nerves.
23
We sought to determine the effectiveness of intraneural
facilitation in DSPN using validated neuropathy scales, objective
static measures, dynamic balance measures, subjective balance
measures, and quantitative posturography balance measures.
24-27
Methods
This institutional review boardeapproved study was conducted at
Loma Linda University, which is a tertiary teaching hospital with
an outpatient physical therapy clinic providing care to a diverse
group of patients. Study subjects were screened from our clinic
between October 2014 and February 2015. Informed consent was
obtained, and the assessment and intervention procedures were
conducted in our physical therapy area.
Inclusion criteria for this study included the following: men
and women with DPN who were from 18 to 85 years of age,
DSPN form of DPN confirmed by a medical doctor, and ability to
hold static balance for a minimum of 5 minutes.
Potential subjects were excluded if they had comorbidities (eg,
open wounds, cardiac disease, other forms of progressive neuro-
logic disease) or peripheral polyneuropathy affecting balance.
Modified Total Neuropathy Scale
The modified Total Neuropathy Scale is scored from 0 to 24 with
each neuropathy rated from 0 to 4 (0 being healthy and 4 being
severe neuropathy). The modified Total Neuropathy Scale severity
levels are divided into 3 levels: 0 to 8 (mild), 9 to 16 (moderate),
and 17 to 24 (severe). The clinical testing for the modified Total
Neuropathy Scale includes muscle strength, vibration sense, pin
sensation level, and muscle stretch reflexes.
28
Static and dynamic balance scales
The NeuroCom SMART Balance Master system
a
computerized
dynamic posturography (CDP) was used. This apparatus consists
of 2 forceplates that can be pitched up and down and in an
anterior-posterior plane. During this test, our subjects wore safety
harnesses and were supported by 2 researchers to minimize the
risk of falling. The subjects stood upright on the center of the
forceplates in a standardized position. In this machine, 2 tests
were used. The first was the Sensory Organization Test (SOT),
which assesses 3 sensory systems that affect postural control
(visual, somatosensory, and vestibular). Six different conditions
are tested consecutively with three 20-second trials. In step 1 the
patient is required to stand still with eyes open (all sensory in-
formation available); in step 2 the patient is required to stand still
with their eyes closed; in step 3 the surround moves as the patient
moves; in step 4 the forceplate moves as the patient moves; in step
5 the patient closes their eyes and the forceplate moves as the
patient moves; and in step 6 the surround and forceplate move as
the patient moves. We assessed the composite equilibrium and
static balance scores.
29-31
The second was the limits of stability
(LOS) test, which quantifies control of the center of gravity. The
patient is required to voluntarily sway in 8 directions without
losing their balance. The LOS test includes reaction time, move-
ment velocity, end point excursion, maximum excursion, and
directional control. We took the composite scores of reaction time,
movement velocity, end point excursion, maximum excursion, and
directional control from the 8 directions.
Activities-specific Balance Confidence scale
The Activities-specific Balance Confidence (ABC) scale
32
is a
subjective measure of confidence in performing several activities
without losing balance or suffering a sense of wobbliness. It is a
16-item self-report measure in which subjects rate their balance
confidence for performing certain activities. Each item ranges
from 0 to 100. A score of zero implies falling, and a score of 100
implies patient’s confidence of stability. The total score of this
scale is derived by adding all items together and then
dividing by 16.
Implementation protocol
The patients were first assessed by a physician and determined to
have DPN. The physician then referred the patients to our clinic
for physical therapy using intraneural facilitation. At the start of
therapy, the patient was given the option to participate in the study
or to proceed with treatment without study participation. If the
patient chose to participate in the study, baseline data were
recorded from an initial CDP test, a modified Total Neuropathy
Scale assessment, and ABC balance scores. After the initial
assessment, the patient received intraneural facilitation for 10
treatments. On the 12th session, the baseline tests were repeated,
and follow-up data were recorded for analysis.
Data collection
Pretreatment assessment included baseline demographic data, the
modified Total Neuropathy Scale, SOT and LOS test scores, and
the ABC scale.
Posttreatment data were collected for these same measures
after 10 sessions of intraneural facilitation treatment.
Data management and analysis
Data management
Two researchers conducted data management using coding man-
uals for all study measures. All study data were initially reviewed
to identify missing values. Methods for missing value adjustment
included imputation, list-wise deletion, or case-wise deletion. All
modifications were recorded in the data coding manual for future
missing data analysis.
List of abbreviations:
ABC Activities-specific Balance Confidence
CDP computerized dynamic posturography
DM diabetes mellitus
DPN diabetic peripheral neuropathy
DSPN distal symmetric polyneuropathy
LOS limits of stability
SOT Sensory Organization Test
2 A. Alshahrani et al
www.archives-pmr.org
Data analysis
Data were analyzed using SPSS Statistics 22.
b
Means and SDs
were calculated for the outcome measures separately pre- and
postintervention. Paired ttest was used to detect significant change
in SOT, reaction time, movement velocity, end point excursion,
maximum excursion, and directional control between pre- and
postintervention. Wilcoxon signed-rank test was used to compare
differences in directional control and modified Total Neuropathy
Scale between pre- and postintervention. A Pvalue of <.05 was
considered significant.
Results
Of 25 subjects screened for our study, 17 met inclusion criteria
and were enrolled. Of these, 13 completed the study (fig 1). Four
subjects did not complete the study: 1 developed a foot infection,
1 had insurance problems that prevented ongoing therapy, and 2
elected to exit the study because of time restraints. Subject de-
mographics are listed in table 1.
The modified Total Neuropathy Scale showed significant reduc-
tion from pre- and posttreatment measurements (PZ.001) (table 2).
For changes in the SOT, we found a significant increase from pre- and
posttreatment measurements (PZ.012) (table 2). For the LOS test
components, the movement velocity showed a significant increase
from pre -to posttreatment measurements (PZ.023) (table 2). The
remaining measures of reaction time, directional control, end point
excursion, maximum excursion, and the ABC scale showed a trend
toward improvement but did not show statistically significant differ-
ences before or after intraneural facilitation (see table 2).
Discussion
The results of our study are consistent with previous reports
indicating that patients with DSPN are more susceptible to falls
during static and dynamic conditions.
14,19,33
In addition, our re-
sults show that intraneural facilitation can improve neuropathy
symptoms as measured by the modified Total Neuropathy Scale
(PZ.001), static balance or SOT (PZ.012), and dynamic balance
or movement velocity (PZ.023) scores. All other LOS test
components (reaction time, directional control, end point excur-
sion, and maximum excursion) showed a trend toward posttreat-
ment improvement but were not statistically significant. Medical
records indicating the degree of glycemic control were not
available to researchers for all subjects.
We chose to use the modified Total Neuropathy Scale in our
study because it was easy to use and is a valid tool.
34
CDP has
been used extensively in the literature for different conditions as a
validated tool to measure static and dynamic balance.
35-37
Whit-
ney et al
38
looked at the relation between falls history and CDP
scores. They found that scores <38 increased the likelihood ratio
for recognizing repeated fallers in the last 6 months. On subjects
with diabetes, Simmons et al
26
measured postural instability in 2
groups: those with or without cutaneous sensory discrepancies and
a control nondiabetic group. They found that CDP scores are less
for subjects with cutaneous sensory discrepancies; therefore, they
are more likely to have postural instability. In another study, Di
Nardo et al
39
found that CDP distinguished between subjects with
DM with and without peripheral neuropathy.
Although many interventions have tried to mitigate the effect
of DPN through exercises, it remains a progressive disease with
few effective interventions. There are few systematic physical
therapy approaches that are typically used in treating patients with
DPN. For instance, Kochman
40
studied the use of monochromatic
infrared energy plus strengthening, stretching, and balance exer-
cises on patients with DPN to improve balance. The author re-
ported improved balance and a reduction in the number of falls.
Mueller et al
41
investigated weight-bearing exercises versus none
weight-bearing exercises on patients with DPN. The weight-
bearing group revealed significant improvement over the none
weight-bearing group.
The effects of therapeutic rehabilitation on balance in patients
with DPN have included modalities,
42
combining modalities with
exercises,
40
exercises,
41,43
and assistive devices.
44
Ashton-Miller
et al
44
divided subjects into 2 groups. One group used a single-
point cane, and the other group did not use a cane. In the single
point cane group, they found a reduction in failure rate during
weight transfer to unipedal stance. Richardson et al
43
divided
Fig 1 Subject screening and completion. Abbreviations: ABC, ac-
tivities of balance confidence; INF, intraneural facilitation; LOS, limit
of stability; mTNS, modified total neuropathy scale; SOT, sensory or-
ganization test.
Table 1 Patient demographics (NZ13)
Demographic Minimum Maximum Mean SD Male Female
Age (y) 49 73 65.157.548
Sex (n) 7 6
Intraneural facilitation for neuropathy 3
www.archives-pmr.org
subjects into 2 groups. One group received open and closed chain
ankle strengthening, wall slides, and single-leg stance, and the
other group received neck flexion and scapular stabilization ex-
ercises. In the ankle exercises group, they found significant im-
provements in tandem stance, single-leg stance, and functional
reach. Mueller
41
studied weight-bearing exercises versus none
weight-bearing exercises in patients with DPN. The
weight-bearing group showed significance improvement over the
noneweight-bearing group in the 6-minute walk distance and
daily step counts. Exercise may play an important role in patients
with DPN. On the other hand, exercise usually needs weight
bearing and utilization of painful limbs. Also, recent studies
highly recommended minimal physical activity for patients with
DPN to prevent adverse events.
45,46
To decrease pain, paresthesia,
and lesions associated with DPN through physical therapy, we
should limit patients participating with exercise activities to
enhance functional outcomes.
45,46
The present study demonstrates
decreased neuropathic symptoms and improved balance using
intraneural facilitation. By reducing patient neuropathic symp-
toms, intraneural facilitation may enhance patient participation in
therapeutic exercise programs and form a bridge between the
inactive painful patient with diabetes and the active nonpainful
patient with diabetes who can exercise.
The intraneural facilitation intervention is a novel manual
physical therapy approach with anecdotal evidence in reducing
peripheral neuropathy symptoms. The main concept of intraneural
facilitation is the use of 2 manual holds. The first hold is called
facilitation hold (fig 2) and includes putting the contralateral joint
in a maximal loose-pack position that is comfortable to the pa-
tient. For example, the ankle joint on the contralateral side is
placed in full planter flexion and inversion. This position is sus-
tained during the whole session with a stretch strap. It is important
to note that there is no muscle activity in the joint where the
facilitation is occurring, only a slight stretch. We hypothesize that
with the joint in this position, the nerve will move further than the
artery because the artery has more elastin. With increased neural
excursion in relation to the artery, the nutrient vessels that are
clustered at the joint will be stretched. This stretch may enlarge
the opening at the junction of the artery and bridging nutrient
vessel, therefore consistently creating a vascular bias into the
neural epineurial capillaries. Theoretically, this creates increased
epifascial vascular pressure.
47
Although anecdotally the effects of
intraneural facilitation were observed in the clinic, the authors are
unaware of other research evaluating the effects of nonextreme
joint positions on nutrient vessel blood flow. Lundborg and
Rydevik
48
described a relation between pathologic neural
stretching with fascicle deformation and a reduction of blood flow
in the nutrient vessels. The authors found it interesting that a
relation between neural stretching, albeit extreme, and nutrient
vessel blood flow did not exist. However, Lundborg
48
did not
study how the nonpathologic gentle holds would affect neuro-
vascular blood flow in nutrient vessels.
With increased endoneurial edema and a strong perineurium,
the pressurized blood flow may not push through the
Table 2 Changes in mTNS, SOT, LOS test, and ABC scale (NZ13)
Preintervention, Mean SD Postintervention, Mean SD Mean Difference 95% Confidence Interval P
mTNS 10.624.37 7.774.19 2.85 11.28 to 39.60 .001*
SOT 53.7721.81 6614.32 12.23 0.21 to 2.38 .012
y
LOS component
RT 0.910.62 0.810.36 0.10 0.46 to 0.25 .544
y
DCL 55.4432.57 63.1520.45 7.71 15.38 to 30.80 .834*
EPE 39.6823.61 48.3117.15 8.62 10.03 to 27.28 .334
y
MVL 1.991.25 3.281.26 1.29 0.21 to 2.38 .023
y
MXE 54.3131.87 68.4624.14 14.15 11.28 to 39.59 .249
y
ABC 71.4225.78 78.0217.01 6.60 NA .119
y
Abbreviations: DCL, directional control; EPE, end point excursion; mTNS, modified Total Neuropathy Scale; MVL, movement velocity; MXE, maximum
excursion; NA, not applicable; RT, reaction time.
* From Wilcoxon signed-rank test.
y
From paired ttest.
Fig 2 Facilitation hold includes positioning the contralateral ankle
joint in a maximal loose-pack position of plantar flexion and inver-
sion. This position is maintained throughout the entire session.
4 A. Alshahrani et al
www.archives-pmr.org
transperineurial vessels that cross the perineurium into the endo-
neurial capillaries. A second hold or mild stretch is necessary to
bias the increased epineurial blood flow past the perineurium into
the endoneurial capillaries. This hold potentially provides an
unweighting pressure. The second hold or stretch will also enable
the therapist to bias circulation in the neural structures that appear
to be most affected. For example a hamstring stretch would bias
blood flow into the sciatic nerve microvasculature (fig 3). Previous
studies demonstrated short-term exercise effects on endoneurial
capillaries, including stimulating endothelial vasodilation,
enhancing endoneurial blood flow, improving abnormal nerve
perfusion, increasing the release of nitric oxide, and enhancing the
concentration of Na/K ATPase.
49-53
We hypothesize that improve-
ments in the modified Total Neuropathy Scale of our subjects were
caused by these immediate vascular changes that occurred in the
treated extremities; however, more research is need to substantiate
this.
23
Medical records indicating the degree of glycemic control
were not available to researchers for all subjects.
Study limitations
Our study limitations include the potential for bias with the
modified Total Neuropathy Scale assessment because the clinician
who provided the treatment also assessed the modified Total
Neuropathy Scale pre- and postintervention. Other limitations
were not having a control or sham group and the small sample size
that does not allow for generalization of our study findings.
Moreover, this study only measured short-term benefits of the
intervention.
Conclusions
This pilot study showed that intraneural facilitation improves
static and dynamic balance measures and neuropathy symptoms
using validated measures in patients with diabetic DSPN. Whether
the improvements in balance measures noted in the intervention
subjects translate into decreased fall risk in daily life is uncertain.
However, given the minimal risk associated with intraneural
facilitation, we believe our results warrant further study of this
technique in patients with diabetic and idiopathic DSPN to
establish long-term benefits, measure the effect of intraneural
facilitation on pain measures, and if possible use a control or
sham group.
Suppliers
a. NeuroCom SMART Balance Master; Natus.
b. SPSS Statistics 22; IBM.
Keywords
Diabetes mellitus; Diabetic neuropathies; Musculoskeletal
manipulations; Rehabilitation
Corresponding author
Eric Johnson, DSc, 24951 North Circle Dr, Nichol Hall A-712,
Loma Linda, CA 92350. E-mail address: ejohnson@llu.edu.
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... Intraneural facilitation is a novel form of manual physical therapy based on the principle of restoring vascular flow at the arteriae or vasa nervorum in peripheral nerve. 1 Intraneural facilitation has been suggested to improve clinical function in patients with diabetic-associated polyneuropathy, a model for ischemic neuropathy. 1 Carpal tunnel syndrome (CTS) is a common entrapment neuropathy where regional compression in the carpal tunnel leads to edema, increased endoneural pressure, and nerve ischemia. 2,3 During this feasibility/pilot study, we sought to assess the efficacy of intraneural facilitation compared to sham control on improving symptom severity, functional status, and ultrasonography (US) measurements of the median nerve in patients with CTS. ...
... We hypothesize that intraneural facilitation can reverse the regional increased pressure and ischemia in CTS by the use of 3 manual holds designed to stretch muscles, mobilize joints, traction skin and connective tissue, and bias blood flow from surface arteriae or vasa nervorum back into intraneural vessels of the median nerve. 1,9 Intraneural facilitation technique ...
... The first hold gently stretches vessels to enlarge the opening at the junction of the artery and bridging vessel. 1 The constriction of transperineural vessels from endoneural edema creates a valve-type mechanism that further decreases endoneural capillary circulation. 9 A second hold is intended to drive transperineural blood flow past this stricture into the endoneural capillaries. ...
Article
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Objective To perform a pilot study to assess the efficacy of intraneural facilitation (INF), a novel manual technique, in the treatment of carpal tunnel syndrome (CTS). Design Patients with clinical and electrodiagnostic (EDX) evidence of CTS were randomized into INF or sham groups. Setting EDX laboratory in a university medical center. Participants Patients referred to our EDX laboratory were screened based on nerve conduction studies (NCS) that were diagnostic for distal median neuropathy at the wrist or CTS. 14 subjects were enrolled, 4 subjects withdrew prior to randomization, with the remaining 10 subjects divided equally between treatment and control groups. There was a 9:1 female-to-male gender ratio and average duration of symptoms was 28.5 months. Interventions Treatment was performed twice weekly for 3 weeks. Main Outcome Measures Primary outcomes were the Boston CTS Questionnaire (BCTQ) and functional status scale (BFSS) at enrollment, and both at 1 week and 3 months after completion of intervention. A secondary outcome was ultrasound (US) of the median nerve performed at baseline and one week after intervention. Results Ten subjects completed the trial, 5 each in the treatment, and 5 each in the sham groups. The total percentage change in BCTQ and BFSS scores decreased at baseline, 1 week, and 3 months after intervention. However, there was no difference between control and INF group. Within group differences showed non statistical significance differences for all the groups except for the BCTQ questionnaires after 3 months of INF therapy was completed (p=0.043) compared to baseline. Between group differences showed large effects for the BCTQ questionnaires (d=1.933), and wrist-forearm ratio (WFR) 1 week after completion of intervention. Conclusions This pilot study suggests that INF might improve symptoms and possibly function but did not improve median nerve CSA or WFR in CTS at follow-up evaluation 3 months after completion of intervention.
... Of the limited evidence available, balance confidence (ABC-16) has been reported to be 11% lower in older adults with diabetes who were fallers than in non-fallers (8) and indicative of a moderate level of physical functioning (9) in older adults with diabetic peripheral neuropathy (DPN); (ABC-16: 71.42%) (10). However, balance confidence (ABC- 16) has also been reported to be similar between older adults with and without diabetes despite subtle but clear diabetesrelated degradation of sensory functions (visual, vestibular and somatosensory) and worse balance performance (8). ...
Article
Objectives: The short version of the Activities-Specific Balance Confidence Scale (ABC-6) is advantageous in busy clinical or research settings because it can be administered in less time than the original 16-item Activities-Specific Balance Confidence Scale (ABC-16). This pilot study examined the convergent, discriminant and concurrent validity of the ABC-6 in older adults with diabetes mellitus with and without diagnosed diabetic peripheral neuropathy (DPN). Methods: Thirty older adults (aged ≥65) were age- and sex-matched in 3 groups: 10 with diabetes (DM group), 10 with diagnosed DPN (DPN group) and 10 without diabetes (no-DM group). Balance confidence was quantified by the ABC-16, which includes the ABC-6. Potential correlates were evaluated in physical and psychological domains. Results: The ABC-6 and ABC-16 balance confidence scores were strongly correlated (r=0.969; p<0.001; convergent validity). The ABC-6 revealed significant differences in balance confidence between the no-DM and the DM groups (p<0.001; discriminant validity), whereas the ABC-16 did not (p>0.05). The ABC-6 was moderately, but significantly, correlated with physical activity level (r=0.528; p=0.017), mobility (r=-0.520; p=0.027), balance (r=0.633; p=0.003), and depressive symptoms (r=-0.515; p=0.020) in the DM study groups (concurrent validity). Conclusions: The ABC-6 and ABC-16 had excellent convergent validity, and both ABC scales had similar concurrent validity. However, the ABC-6 was more sensitive in detecting subtle differences in balance confidence in older adults with diabetes without diagnosed DPN than the ABC-16. Overall, this pilot study provided evidence of the validity of the ABC-6 in older adults with diabetes. Further exploration involving a larger sample size is recommended to confirm these findings.
Article
Background Stay-at-home orders associated with the SARS-CoV-2 (COVID-19) pandemic were particularly important for older adults with type 2 diabetes, at risk for severe COVID-19 complications. In response, research shifted to remote telehealth methodology. Study participant interests, equipment needs, and ability to adapt methods to the remote/telehealth environment were unknown. Study purposes to assess (1) resource needs (internet/devices accessibility), (2) future telehealth interests, and (3) ability to adapt common research and clinical measures of glycemic control, physical function, activity measures, and quality of life outcomes to a telehealth setting. Method Twenty-one participants with type 2 diabetes and peripheral neuropathy were recruited from a longitudinal study (11 female; age: 66.3 ± 8.3 years; DM: 15.1 ± 8.7 years). Technology needs and future telehealth interests were assessed. A glycemic measure (HbA1c), a five-times chair rise, a one-week activity monitor, and surveys (self-efficacy, depression, and balance) were collected. All aspects of the study were completed remotely over email and video/phone call. Results Twelve participants used computers; nine used phones for study completion. Participants had the following resource needs: connectivity (n = 3), devices (n = 6), and technical support (n = 12). Twenty people expressed interest in participating in future telehealth studies related to balance, exercise, and diabetes management. Methodological considerations were primarily the need for assistance for participants to complete the home HbA1c test, five-time chair rise, wearable activity monitoring, and surveys. Conclusions Older adults with type 2 diabetes and peripheral neuropathy would need technological and personal assistance (connection, device, guidance) to complete a long-term telehealth intervention. Despite technology needs, participants were interested in telehealth interventions. Clinical Trial Parent study, “Metatarsal Phalangeal Joint Deformity Progression—R01 (NCT02616263) is registered at https://clinicaltrials.gov/ .
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Chemotherapy-induced peripheral neuropathy (CIPN) is a common, potentially reversible side effect of some chemotherapeutic agents. CIPN is associated with decreased balance, function and quality of life (QoL). This association has to date been under-investigated. To profile patients presenting with CIPN using the modified Total Neuropathy Score (mTNS) in this cross-sectional study and to examine the relationship between CIPN (measured by mTNS) and indices of balance, quality of life (QoL) and function. Patients receiving neurotoxic chemotherapy regimens were identified using hospital databases. Those who did not have a pre-existing neuropathy were invited to complete mTNS, Berg Balance Scale (BBS), timed up and go (TUG), and FACT-G QoL questionnaire. mTNS scores were profiled and also correlated with BBS, TUG and FACT-G using Spearmans correlation coefficient. A total of 29 patients undergoing neurotoxic chemotherapy regimens were tested. The patients mTNS scores ranged between 1 and 12 (median = 5), indicating that all patients had clinical evidence of neuropathy on mTNS. No significant correlations were found between mTNS and BERG (r = -0.29), TUG (r = 0.14), or FACT-G (r = 0.05). This study found a high prevalence of CIPN in patients treated with neurotoxic chemotherapy regimens. The mTNS provided a clinically applicable, sensitive screening tool for CIPN which could prove useful in clinical practice. mTNS did not correlate with BBS, TUG or FACT-G in this sample, possibly due to relatively mild levels of CIPN and consequent subtle impairments which were not adequately captured by gross functional assessments.
Article
Full-text available
This prospective, correlational study sought to identify a clini- cally feasible, valid measure of taxane-induced peripheral neuropathy that correlated with impairments in balance, physical performance, pain, and quality of life (QOL). In all, the study included 20 breast can- cer patients who completed taxane chemotherapy and 20 healthy women who were matched by age, height, and weight. All participants completed a testing session that included measures of peripheral neu- ropathy, balance, physical performance, pain, and QOL. Modified Total Neuropathy Scores (mTNS) discriminated between women in the breast cancer and control groups. Positive correlations were found between the mTNS and the Total Neuropathy Score (r = 0.99; P < 0.001) and physi- cal performance (r = 0.654; P = 0.002). Negative correlations were found between the mTNS and measures of balance (r = -0.638; P = 0.002) and QOL (r = -0.615; P = 0.004). Pain was experienced by 70% of the women with breast cancer. Pain intensity scores did not correlate with any mea- sure of peripheral neuropathy. The mTNS may be a valid clinical measure to monitor the severity of peripheral neuropathy in women receiving a taxane for breast cancer, because it correlated strongly with the TNS. In addition, because the mTNS was correlated with measures of balance, physical performance, and QOL, it may help clinicians to identify patients who may benefit from rehabilitative services. Pain and peripheral neu- ropathy may need to be assessed separately.
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The main objective of this study was the estimation of intrasession reliability of the limits of stability (LOS) test conducted on a force platform as an alternative measurement to standard posturography in quiet standing. Fifteen healthy adults took part in the experiment. The standardized measurement protocol of the LOS test was proposed. It consists of three phases – 1st phase – 10s of quiet standing, 2nd phase – the maximal forward leaning in a self paced manner, and 3rd phase – maintenance of maximal forward leaning position. The analysis of variance Friedman’s ANOVA and Repeated Measures ANOVA/MANOVA was used to diagnose the differences between 10 consecutive trials of the LOS test. In order to establish reliability of the test, the intraclass correlation (ICC) procedure was used. We presented different ways of maximal center of pressure (COP) excursion estimates. The results of this study show no significant differences between the chosen parameters of the LOS test. Moreover, the measurement of the range of COP excursion, which is most commonly analyzed in such tests, showed to be quite reliable with ICC2,1 above .85. LOS test conducted along the standard procedure should be considered as a very useful method in clinical and research conditions. Still the specific parameters of the LOS test should be given more thorough insight, but it is a very good alternative to quiet standing posturography.
Article
Objective To determine the effects of weight-bearing (WB) versus nonweight-bearing (NWB) exercise for persons with diabetes mellitus (DM) and peripheral neuropathy (PN).DesignRandomized controlled trial with evaluations at baseline and after intervention.SettingUniversity-based physical therapy research clinic.ParticipantsParticipants with DM and PN (N=29) (mean age ± SD, 64.5±12.5y; mean body mass index [kg/m2] ± SD, 35.5±7.3) were randomly assigned to WB (n=15) and NWB (n=14) exercise groups. All participants (100%) completed the intervention and follow-up evaluations.InterventionsGroup-specific progressive balance, flexibility, strengthening, and aerobic exercise conducted sitting or lying (NWB) or standing and walking (WB) occurred 3 times a week for 12 weeks.Main Outcome MeasuresMeasures included the 6-minute walk distance (6MWD) and daily step counts. Secondary outcome measures represented domains across the International Classification of Functioning, Disability and Health.ResultsThe WB group showed greater gains than the NWB group over time on the 6MWD and average daily step count (P<.05). The mean and 95% confidence intervals (CIs) between-group difference over time was 29m (95% CI, 6–51) for the 6MWD and 1178 (95% CI, 150–2205) steps for the average daily step count. The NWB group showed greater improvements than the WB group over time in hemoglobin A1c values (P<.05).Conclusions The results of this study indicate the ability of this population with chronic disease to increase 6MWD and daily step count with a WB exercise program compared with an NWB exercise program.
Article
Purpose: Elderly patients are at high risk for falls due, in part, to the loss of sensation in the lower extremities. This study examined the effectiveness of a comprehensive therapy intervention that included monochromatic infrared photo energy for improving foot sensation, balance, and fall status. Methods: Thirty-eight patients, average age 78 years, participated in this study. All patients lacked protective sensation in the lower extremities (documented by the Semmes Weinstein 5.07 monofilament), demonstrated a significant fall risk based on Tinetti scores, and had a history of falling. Patients participated in a mean 12 treatments that consisted of infrared photo energy, neuromuscular re-education, balance and strength training, and stretching exercises. Results: Comparisons of patients' status pre- and post- treatment showed that they improved significantly in lower extremity sensation and balance and that they experienced fewer falls. Conclusion: A comprehensive therapy intervention that includes infrared photo energy has the potential to improve sensation and balance and to reduce fall frequency. These results should be of great interest to patients with peripheral neuropathy, health care providers who treat these patients, and the payor community that incurs the cost of treatment. (C) 2004 Lippincott Williams & Wilkins, Inc.
Article
Distal Sensorimotor Polyneuropathy (DPN) is one of the most common long-term complications of diabetes mellitus. Patients with DPN are at a high risk for falling and its life-threatening consequences. The objective of present study was the evaluation of functional balance in patients with diabetic neuropathy and normal older adults. Thus, present case-control study was designed to test the ability of two fourteen DPN patients and healthy people to control functional balance using Berg Balance Scale (BBS). Furthermore, the correlation between DNE and BBS scores were calculated using the Spearman's correlation coefficient. Comparison of two groups showed a significant decline in the overall score of BBS in DPN patients versus to the healthy control group (P<0.001). The most challenging tasks for DNP patients were single leg stance, tandem standing and forward reaching (P<0.001), followed by standing unsupported with feet together, sit to stand, stand to sit, transfers, standing unsupported with closed eyes, and placing the alternative foot on step or stool while standing unsupported tasks (P<0.05). There was a significant (P<0.001) strong negative (r=-0.77) correlation between DNE and BBS scores. In conclusion, DPN results in a remarkable functional imbalance that may expose these patients to danger of falling during daily activities and becomes more severe as the severity of neuropathy aggravates.
Article
Diabetes is an increasingly important condition globally and robust estimates of its prevalence are required for allocating resources. Data sources from 1980 to April 2011 were sought and characterised. The Analytic Hierarchy Process (AHP) was used to select the most appropriate study or studies for each country, and estimates for countries without data were modelled. A logistic regression model was used to generate smoothed age-specific estimates which were applied to UN population estimates for 2011. A total of 565 data sources were reviewed, of which 170 sources from 110 countries were selected. In 2011 there are 366 million people with diabetes, and this is expected to rise to 552 million by 2030. Most people with diabetes live in low- and middle-income countries, and these countries will also see the greatest increase over the next 19 years. This paper builds on previous IDF estimates and shows that the global diabetes epidemic continues to grow. Recent studies show that previous estimates have been very conservative. The new IDF estimates use a simple and transparent approach and are consistent with recent estimates from the Global Burden of Disease study. IDF estimates will be updated annually.
Article
Diabetic Peripheral Neuropathy (DPN) is a complication of diabetes experienced by more than 30% of all diabetic patients. It causes decreased sensation, proprioception, reflexes, and strength in the lower extremities, leading to balance dysfunction. The purpose of this study was to assess the effectiveness of interventions used by physical therapists to minimize balance dysfunction in people with DPN. Currently, no systematic review exists that explores the effectiveness of these interventions. When conducting this systematic review, we searched the electronic databases CINAHL, EMBASE, Cochrane Review, and Medline using specific search terms for the period from inception of each database to June 2009. Two independent reviewers analyzed the abstracts obtained to determine whether the article focused on balance interventions that are within the scope of physical therapy practice. All study designs were eligible for review with the exception of case reports and systematic reviews. The Delphi criteria was used to assess methodological quality. This literature search and methods assessment resulted in 2213 titles, 82 abstracts, and 6 articles, including 1 randomized controlled trial eligible for inclusion. The 6 articles contained 4 physical therapy interventions including monochromatic infrared energy therapy, vibrating insoles, lower extremity strengthening exercises, and use of a cane. Upon thorough analysis of outcome measures, statistical significance, and clinical relevance, the intervention of lower extremity strengthening exercises was given a fair recommendation for clinical use in treating balance dysfunction in patients with DPN. All others had insufficient evidence to either support or refute their effect on balance in this population.
Article
To investigate the feasibility and preliminary effectiveness of an exercise programme for patients with diabetic complications. In this pre-post design study, 22 patients from a diabetic foot outpatient clinic participated in a 12-week individualized exercise programme, consisting of aerobic and resistance exercise, with specific safety precautions. Feasibility was assessed on the basis of programme adherence, adverse events, achievement of the target training intensity and patient satisfaction. Preliminary effectiveness was evaluated with pre-post-changes in blood glucose regulation (HbA(1c) ), muscle strength (isometric peak torque) and perceived limitations in functioning (Patient Specific Function Scale with visual analogue scale). Twenty patients completed the exercise programme with a high mean attendance (85%). No training-related severe adverse events occurred. The target training intensity was achieved by 70% of the participants. Patient satisfaction was high. HbA(1c) decreased from 8.2% before to 7.8% after the programme (P=0.005), muscle strength increased from 136.4 to 150.4 Nm (P = 0.046) and perceived limitations in functioning decreased from 7.2 to 5.8 mm (P=0.003). The prescribed exercise programme had a potentially positive effect on blood glucose regulation, muscle strength and perceived limitations in functioning in patients with diabetic complications.