Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial.

Abstract

Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group).
People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy.Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes.
This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home.
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594.

Full text

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STUDY PROTOCOLOpen Access
Falls and mobility in Parkinson’s disease: protocol
for a randomised controlled clinical trial
Meg E Morris1*, Hylton B Menz2, Jennifer L McGinley1,3, Frances E Huxham1, Anna T Murphy1,3, Robert Iansek3,
Mary Danoudis1,3, Sze-Ee Soh1, David Kelly1and Jennifer J Watts1,4
Abstract
Background: Although physical therapy and falls prevention education are argued to reduce falls and disability in
people with idiopathic Parkinson’s disease, this has not yet been confirmed with a large scale randomised
controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement
strategy training combined with falls prevention education, (ii) progressive resistance strength training combined
with falls prevention education, (iii) a generic life-skills social program (control group).
Methods/Design: People with idiopathic Parkinson’s disease who live at home will be recruited and randomly
allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each
group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also
have a structured 2 hour home practice program for each week during the 8 week intervention phase.
Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the
intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy.
Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be
used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In
addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary
outcomes.
Discussion: This study has the potential to determine whether outpatient movement strategy training combined
with falls prevention education or progressive resistance strength training combined with falls prevention
education are effective for reducing falls and improving mobility and life quality in people with Parkinson’s disease
who live at home.
Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594
Background
Falls are common in people with idiopathic Parkinson’s
disease (PD) and fall related injuries can be associated
with immobility and reduced quality of life. Many peo-
ple with PD experience difficulties walking and balan-
cing as the disease progresses and this can compromise
their ability to participate in work, family, community
and social activities [1,2]. Previous research suggests
that more than half of people who are diagnosed with
PD experience one or more falls in a given 12 month
period, compared to 30% of older adults who live in the
community [3-8]. The extent to which falls in people
with PD are related to hypokinesia, dyskinesa, postural
instability, rigidity, weakness, cognitive impairment or
medication remains unclear. The associated burden of
disease arising from falls and immobility can impact
adversely on individuals, their families, the healthcare
system and society.
At the present time there is no known cure for idio-
pathic PD. Pharmacological therapy currently provides
the most effective symptomatic treatment for many
movement disorders [9]. Nevertheless freezing of gait,
postural instability and hypokinesia have only a limited
or short-lived response to PD medication in many indi-
viduals [10]. As the disease progresses, PD medications
are adjusted in response to changes in symptoms [11].
* Correspondence: m.morris@unimelb.edu.au
1Melbourne School of Health Sciences, The University of Melbourne, 3010,
Melbourne, Australia
Full list of author information is available at the end of the article
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© 2011 Morris et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.

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Despite the best medical management, motor fluctua-
tions and movement disorders can recur due to progres-
sive cell loss in the substantia nigra pars compacta in
the brainstem and disruption to neural connections to
the frontal lobes, cerebellum and other regions of the
brain [12]. For these reasons, pharmacological manage-
ment is often augmented by physical therapy and falls
education [13].
There are two main approaches to physical rehabilita-
tion for people with PD. Movement strategy training
(MST) teaches individuals how to cope with their move-
ment disorders by using attention, cues, environmental
adaptation, part practice and mental rehearsal [14].
Rather than regulating well learned movements automa-
tically through the defective basal ganglia circuitry, MST
aims to train people to use the frontal cortex in the
initiation and execution of movements and functional
activities. Motor performance is optimised by breaking
down complex movement sequences into small parts
and by teaching people to focus their attention on each
part prior to “whole” task practice [13]. Mental rehearsal
of forthcoming movements, focussing on the movement
while it is occurring and the use of visual or auditory
cues to guide motor performance are additional strate-
gies [13,15]. Other “tricks” include performing the
movement in a different way (e.g., running or dance
steps instead of walking) and using different intent (e.g.,
thinking about getting to the fridge to get the milk
rather than thinking of trying to walk).
The other key approach to improving movement in
people with PD is progressive resistance strength train-
ing (PST) [16-20]. People with PD can become weak
and de-conditioned due to inactivity, disuse and reduced
physical activity associated with hypokinesia and ageing
[17,18]. There is preliminary evidence that PST might
improve muscle strength [18,21,22] with associated
improvements in balance [21] and walking [18,19] in
some people. The extent to which PST prevents falls in
people with PD remains unclear.
Education packages that provide advice about the pre-
dictors of falls and how to prevent them are also
thought to be effective in reducing falls, either as a sin-
gle intervention or as part of a multifaceted treatment
package [23-26]. Although a range of approaches and
methods of delivery have been used, these packages gen-
erally aim to increase awareness of a person’s risk of,
and risk factors for, falling, as well as to help them iden-
tify and access resources to undertake appropriate
interventions.
The primary aim of the current study is to conduct
the first large scale community based trial to investigate
if outpatient physical therapy programs comprising
either (i) MST combined with falls education or (ii) PST
combined with falls education are more effective than a
control group that receives a generic “life-skills” pro-
gram that does not contain any information or advice
about gait, balance, falls, exercise or mobility. We
hypothesise that participation in physical therapy direc-
ted to either MST or PST combined with falls education
will reduce falls relative to participation in the control
group. Participation in an active therapy group is also
predicted to provide significant improvements in mobi-
lity and quality of life, which are not expected to occur
for the control group. The anticipated reduction in falls
rate in the therapy groups is likely to be accompanied
by cost benefits, as we have described in an earlier
paper [27].
Methods
Design
A single blind, parallel-group randomised controlled
clinical trial (RCT) design will be used with two inter-
vention groups and one control group. Because the lit-
erature at the time of study design did not provide
evidence on whether movement strategies were superior
to strengthening, we included one group receiving MST
and another receiving PST. To reflect clinical practice,
each of these groups will also receive a falls prevention
education program [28]. A control group that does not
include physical therapy or falls education will be used
to determine the relative effectiveness of each therapy
approach. Ethical approval to conduct the study has
been gained from the University of Melbourne Health
Sciences Human Ethics Sub-Committee (0828579).
Written consent for publication will be obtained from
the participant or their relative.
Participants
Community dwelling people with PD will be recruited
for the trial from outpatient movement disorder clinics,
community-based rehabilitation programs, PD support
groups and private neurologists in the Melbourne
metropolitan area. Participants will also be recruited
from the local community through advertisements in
local and metropolitan newspapers and newsletters dis-
tributed by Parkinson’s Victoria, Australia. Potential par-
ticipants will be provided with an information pack
describing the study, and invited to return an ‘expres-
sion of interest’ to the study coordinator to be screened
for eligibility. To be included, participants will be
required to have confirmed idiopathic PD, be able to
participate in an outpatient exercise program including
strength training and be willing to complete a falls
calendar for 12 months after therapy. Participants will
be excluded if they score less than 24 on the Mini-Men-
tal State Examination (MMSE) [29], or if they have a
rating greater than 4 on the modified Hoehn and Yahr
scale [30] or if they are on major tranquilizers.
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Sample size
The sample size for the study was determined based on
the falls rates and effect sizes obtained from previous
trials on people with PD and the elderly [6,31,32]. For
each sample size calculation, power was set at 80%,
alpha set at 5%, and the drop-out rate was set at 15%.
For falls, a sample size of 110 was thought to be
required to detect a 20% difference between the groups,
assuming a falling rate of 60% in the control group. For
walking speed, a sample size of 74 was required to
detect a 10% difference between the groups, assuming a
mean (± SD) walking speed in the control group of 58.4
(12.0) m/min. For the “timed up and go” test, a sample
size of 83 was thought to be required to detect a 10%
difference between the groups, assuming a mean (± SD)
timed up and go in the control group of 13.78 (2.99)
sec. Thus, to ensure adequate statistical power for each
of these outcome measures, the sample size for the
study would optimally be 110 per group (total n = 330).
Approximately 60 percent of control group participants
are expected to fall between Test 1 (baseline) and Test
4 (12 months after therapy) with falls reduced to around
40% in the two active therapy groups.
Interventions
Movement strategy training (MST)
All interventions will be delivered by therapists trained
in the standard protocols. The MST group will attend
two hours of physical therapy weekly in an outpatient
setting for eight sequential weeks, in small classes of
three or four participants. The MST group will follow a
program based upon the principles of physical rehabili-
tation outlined in Morris et al., [13,33,34]. Table 1 sum-
marises the content and dosage of the MST program
with guidelines for therapists. Movement strategies
emphasise task specific practice of everyday functional
actions such as rolling over, standing up, walking, cross-
ing obstacles and turning. These tasks are practised with
strategies such as visual or auditory cues, mental rehear-
sal and movement planning, conscious attention during
the task, and breaking the task into a sequence of smal-
ler components. The program is tailored to movement
impairments, activity limitations, and cognitive status
and learning ability. An individualised home practice
session of strategies to practise within the home or com-
munity will also be completed once a week. Structured
falls risk education will also be provided each week,
based upon the content of a booklet Don’t fall for it.
Falls can be prevented! - A guide to preventing falls for
older people produced by the Australian Commonwealth
Department of Health and Ageing [28]. This booklet
contains information on topics such as medication,
vision, footwear, regular activity and safe environments.
A single home visit will be conducted by a trained
therapist or nurse to check compliance with the therapy
program.
Progressive resistance strength training
The PST intervention group will attend a physical ther-
apy program of equivalent length to the MST group;
two hours weekly for eight weeks in an outpatient set-
ting, in small classes of three or four participants. The
PST program will include strengthening exercises for
quadriceps, hip and trunk extensor muscles, hip abduc-
tors, calf, and ankle dorsiflexors, tailored to the indivi-
dual’s strength and functional ability. Table 2
summarises the content and dosage of PST with guide-
lines for therapists. Where possible, training is per-
formed in functional tasks such as standing up from a
chair, stepping up onto a step etc, using body weight,
weighted vests and Thera-band®to progress the resis-
tance. Structured falls risk education will also be pro-
vided each week, in a manner identical to the MST
group, using the same Don’t fall for it. Falls can be pre-
vented! - A guide to preventing falls for older people
resource booklet [28]. An individualised home practice
session of strengthening exercises will also be completed
once per week. A single home visit will be conducted by
a trained therapist or nurse to check compliance with
the therapy program.
Life-skills control group
The control intervention will be of equivalent duration
to the MST and PST groups, delivered in small groups
in outpatient settings over 8 weekly two hour sessions.
Each session will be led by trained occupational thera-
pists, physical therapists, speech pathologists or social
workers, and include content such as relaxation, games,
or communication activities. Guided discussion will also
include topics such as the impact of PD on the indivi-
dual and family, support and resources available, and
fatigue management. None of the content will relate to
walking, balance or falls risk education. A home session
of reflection activities and relaxation practice will also
be completed once per week.
Outcome measures
All participants will be tested by trained blinded asses-
sors before and after the 8 week interventions, and at 3
months and 12 months after completion of the interven-
tion phase. Participants will keep a falls calendar for 12
months after therapy. Consistent with the recommenda-
tions of the Prevention of Falls Network Europe (PrO-
FaNE) group, a fall will be defined as “an unexpected
event in which the participant comes to rest on the
ground, floor, or lower level” [35]. Each time a partici-
pant falls, they will tick the date on the falls calendar
and then telephone a falls hotline where they will be
interviewed about the nature of the fall, circumstances,
injuries sustained, healthcare required and other factors.
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The falls interview questions are given in Figure 1, and
an example of a calendar page is provided as an addi-
tional file (see Additional File 1).
The three falls outcomes that are the primary out-
comes are (i) the number of fallers in each group (ii)
the number of multiple fallers in each group and (iii)
the falls rate over 12 months in each group. Secondary
outcome measures will include the number of injurious
falls, defined as a fall requiring a visit to a health service
provider. Additional secondary outcome measures
include mobility, measured by quantifying walking speed
using the 6m walking test and the Timed Up and Go
Test [36]. Activity limitations will be quantified using
the United Parkinson’s Disease Rating Scale sections II
and III [37]. Quality of life will be measured using the
Parkinson’s Disease Questionnaire-39 (PDQ39) [38] and
EuroQol-5D [39]. Changes in health-related QoL will be
measured using both a PD-specific measure (PDQ-39)
and a generic utility instrument (Euroqol-5D) adminis-
tered at baseline, immediately post-intervention, 3
months, and 12 months. Safety during the intervention
phase will be assessed by time to first fall, and monitor-
ing of adverse events related to therapy.
Statistical analysis
Statistical analysis will be undertaken using IBM SPSS
version 19.0 (SPSS Corp, Chicago, Ill, USA) and STATA
8 (Stata Corp, College Station, Tex., USA) statistical
software. All analyses will be conducted on an inten-
tion-to-treat principle using all randomised participants.
Demographic characteristics and baseline data will be
summarised by descriptive statistics. For the primary
Table 1 Movement strategy training protocol
Principles of Movement Strategy Training [13,33,34,44]
• Use visual, auditory or somatosensory cues to optimise timing and amplitude of actions, movements and their components
• Use attentional strategies such as focussing on key movement components, visualising correct amplitude or pattern, mental rehearsal,
visualisation
• Break down complex movements into parts and focus on each segment in sequence
• Practise individual components of activities separately before incorporating into whole
• Incorporate cues and attentional strategies into functional tasks with reference to home environment.
• Individualise strategies, repetitions, and environmental context, with consideration to level of disability and functional difficulties
• For people with mild levels of impairment, consider practising dual tasking to promote motor learning. For those with advanced disease,
avoid dual tasks
Activities
Walking
Walking with visual cues or attention strategies to correct step size to criterion length. Incorporate stopping and starting, with auditory cues if gait
initiation difficulties.
Turning
Walking while turning, in either ‘arc’ or ‘clock’ (on the spot) patterns. Cues may include tape on floor, cue cards, photos, with attention to step size
and placement.
Practise different turn magnitudes and turn activities relevant to home and community environment.
Reaching in Standing
Practice varied reaching activities in functional contexts, progressing to reach for objects of different weights and sizes at differing heights.
Emphasise conscious attention to postural stability and position prior to reach.
Sit to stand
Modify chair height to assist or challenge patient, practise from different styles of chairs, chair height and compliances of chair and floor surface.
Emphasise conscious attention to movement sequence in conjunction with amplitude, speed and flow of movement. Use visual cues such as
photos or cue cards with key words.
Transfer from chair to chair
Practice transferring from chair to chair with the seats in different configurations, including at tables and in theatre rows. Encourage conscious
attention to movement components in sequence and ensure safety. Visual and auditory cues may include cue cards with key words or pictures.
Getting up from bed
Emphasise normal timing and maintain momentum. Practise from same side of bed as person uses at home. Use assistive devices such as a
bedpole where appropriate. Attentional strategies should focus on position in bed, sequence and speed and flow of movement. Cues could include
cards with key words, photos or pictures.
Protective stepping in standing
Practise taking quick, large steps in different directions. Practise responding quickly to a verbal cue to step, or to a tug or push in a known or
unknown direction. Encourage attentional strategies, such as focussing on visualising big and fast steps in the direction of loss of balance.
Complex walking tasks
Practice dual or multi-tasks, and obstacle course negotiation. Encourage mental preparation or movement visualisation, with pre-planning of the
obstacle course and recognition of potentially difficult areas.
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outcome measures, the number of fallers and multiple
fallers in each group will be compared by calculating
relative risks. The number of falls and falls rate per per-
son per year in the three groups will then be compared
using negative binomial regression models. This
approach takes into account all falls and adjusts for
varying duration of follow-up [40,41]. As a safety mea-
sure, time to first fall during the intervention period will
be analysed using Kaplan-Meier survival analysis, and
comparisons between groups will be made using the
Mantel-Cox log rank test. The continuously-scored sec-
ondary outcome measures at baseline and the follow-up
appointments will be compared using analysis of covar-
iance with baseline scores and intervention group
entered as independent variables [42,43]. For categorical
secondary outcome measures, relative risks will be used
to analyse differences between the groups.
Discussion
This RCT will be one of the first investigations of the
effects of physical therapy interventions on falls in peo-
ple with idiopathic PD. It will also be one of the first
PD studies to collect detailed data on falls over a 12
month period, using a falls calendar coupled with tele-
phone interviews. This will provide an accurate record
of falls rates in a large cohort from a major metropoli-
tan city. It will also provide data on the contributing
factors to falls in people with PD and the injuries sus-
tained and healthcare required. Such data are not cur-
rently available and will be of benefit to policy makers,
Table 2 Progressive Resistance strength training protocol
2. Principles of Progressive Resistance Strength Training [17,18,20,21,45]
• Safety is paramount. Ensure
○ correct execution of the movement
○ the required number of repetitions and sets is achieved
○ the required level of supervision or support is provided
○ participants advise therapists of any concerns or adverse symptoms
• All exercises will be steadily progressed, either by
○ increasing the number of repetitions (aim for 8-15)
○ increasing the weight or resistance (2% bodyweight increments)
○ altering starting position
○ increasing number of sets (to maximum of 3)
• Progression is guided by
○ the participant’s ability to correctly perform the movement
○ the Modified Perceived Exertion scale (mRPE) [45] - when the exercise level is ≤ 5 on this scale
○ completion of 8-15 repetitions for 1-2 sets
○ clinical judgement of the therapist
Exercises
Sit-to-stand
Sit to stand from chair. Progress with variation of use of arms, vary height of chair and use of weighted vest.
Trunk extension and rotation
Seated, Thera-band®loop under one foot, use both hands, (i) flex elbows until hands touch opposite shoulder, then (ii) rotate and extend trunk.
Lateral pelvic hold/hitch
Subject single leg stance on small step and hand support. Shorten or hitch so pelvis is horizontal and hold for count of 5 - 30 secs. Progression
includes use of weighted vest.
Step-ups
Subjects stand in front of step with hand support nearby. Step up then return, first with right leading, then with left leading. Progression includes
use of weighted vest.
Heel raises
Participants stand facing wall, toes approximately 40 mm from wall. Lean forearms on the wall, then push up onto the balls of the feet. Hold for
count of 10. Progression includes use of weighted vest.
Standing toe raises keeping balance
Standing upright, with back close to wall for safety, raise one forefoot, hold, then down, followed by the other.
Progress to both feet together, then standing toes down on a wedge.
Abdominals
Subject sitting on edge of a chair with a back, with hands on opposite shoulders. Keeping back straight, and abdominals braced, lean backwards a
short distance. Hold for count of 5 - 10.
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healthcare professionals and people living with PD. Data
are also being collected on impairments, disability and
quality of life, allowing examination of the associations
between these variables and falls frequency and severity
in PD.
There are a number of limitations of the current trial.
Participants will all be rated 0-IV on the modified Hoehn
and Yahr Scale [30] and therefore the results cannot be
generalised to those rated V, who are severely disabled. All
measurements will be taken during the day at peak dose of
Date of fall
Time of fall
Location of fall – please detail
Can you describe what caused the fall?
Mechanism of fall – circle appropriate
answer
? trip
? turning
? legs gave way
?dizzy
?slip
? other(specify)
Direction of fall – circle appropriate answer
? Forwards
? sideways
? backwards
? hand
? knee
? straight down
What broke the fall?
? elbow
? hip
? shoulder
? buttocks
? other (specify)
? working well ON ? wearing off ON How well was your medication working at
the time of the fall? Circle appropriate
answer
Did you experience any freezing at the time
of the fall (i.e. did you feel like your feet
were stuck to the floor?)
Were you using a walking aid when you
fell?
? OFF medication ? over and wriggly
? Yes
? No
? Yes
? No
Did you suffer any injuries?
Please detail
? Yes
? No
Did you seek medical attention?
Where?
? Yes
? GP
? No
? Hospital
If you went to hospital, how did you get
there?
? Private car
? Ambulance
? Other (specify)
? Yes
number________________________
? Yes
? Taxi
Were you admitted to hospital overnight?
How many nights did you stay in hospital?
Was your hospital in the Southern Health
network?
Please indicate if you needed to use any of
the following out of hospital health services
after your fall?
? No
? No
? GP
? Parkinson’s specialist
? physiotherapist
? other allied health professional
? radiology (x-ray)
? pathology clinic
Figure 1 Falls interview questions.
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the levodopa medication cycle and therefore the effects of
medication cannot be separated from the effects of physi-
cal therapy and falls education. The response to strength
training, strategy training or life-skills social interventions
in the “off’ phase of the levodopa cycle cannot be ascer-
tained. Moreover the results can only be generalised to
outpatient therapy services and may not be directly applic-
able to home or hospital care.
Conclusions
This RCT will show the extent to which outpatient physi-
cal therapy programs combined with falls prevention
education are effective for reducing falls and improving
mobility and life quality in people with PD who live in
the community. Moreover it will show whether strategy
training or strength training is more effective than a con-
trol intervention for people with mild-moderately severe
PD, when combined with education on falls prevention.
Additional material
Additional file 1: Falls Calendar. An example of a page from the Falls
Calendar.
List of abbreviations
PD: Parkinson’s Disease; MST: Movement strategy training; PST: Progressive
resistance strength training; RCT: Randomised controlled trial; PDQ39:
Parkinson’s Disease Questionnaire-39.
Acknowledgements
This project has been funded by a Michael J Fox Foundation (US) Clinical
Discovery Grant. HBM is currently a National Health and Medical Research
Council Fellow (Clinical Career Development Award, ID: 433049).
Author details
1Melbourne School of Health Sciences, The University of Melbourne, 3010,
Melbourne, Australia.2Musculoskeletal Research Centre, Faculty of Health
Sciences, La Trobe University, 3086, Australia.3National Parkinson Foundation
Center for Excellence, Clinical Research Centre for Movement Disorders and
Gait and Victorian Comprehensive Parkinson’s Program, Kingston Centre,
Warrigal Rd, Cheltenham, 3092, Australia.4Centre for Health Economics,
Monash University, Building 75, Clayton, 3168, Melbourne, Australia.
Authors’ contributions
MM, JM, FH, RI, HM, JW and AM conceived the idea for the study and
participated in the design of the study as well as project management, data
analysis, sample size calculations and data interpretation. AM and MD
contributed to the design and assisted with subject recruitment and project
management. MM, JM, HB, DK, MD and SS drafted the manuscript for
submission and will be involved in compiling patient information and
analyzing results. All the authors have read and approved the manuscript.
Competing interests
The authors declare that they have no competing interests.
Received: 15 June 2011 Accepted: 31 July 2011 Published: 31 July 2011
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Pre-publication history
The pre-publication history for this paper can be accessed here:
http://www.biomedcentral.com/1471-2377/11/93/prepub
doi:10.1186/1471-2377-11-93
Cite this article as: Morris et al.: Falls and mobility in Parkinson’s
disease: protocol for a randomised controlled clinical trial. BMC
Neurology 2011 11:93.
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