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502799 CRE28410.1177/0269215513502799Clinical RehabilitationSkidmore et al.
1 Department of Occupational Therapy, University of Pittsburgh
School of Health and Rehabilitation Sciences, Pittsburgh, PA,
2 Rehabilitation Institute, University of Pittsburgh Medical
Center, Pittsburgh, PA, USA
3 Department of Physical Medicine and Rehabilitation, University
of Pittsburgh School of Medicine, Pittsburgh, PA, USA
4 Rotman Research Institute at Baycrest, Toronto, ON, Canada
5 Department of Occupational Science and Occupational
Therapy and Graduate Department of Rehabilitation Sciences,
University of Toronto, Toronto, ON, Canada
interventions: lessons learned
from a pilot study examining
strategy training in acute stroke
Elizabeth R Skidmore1,2,3, Deirdre R Dawson4,5,
Ellen M Whyte3,6,7, Meryl A Butters6,7, Mary Amanda Dew6,7,
Emily S Grattan1,2, James T Becker6 and Margo B Holm1
Objective: To examine the feasibility of a strategy training clinical trial in a small group of adults with
stroke-related cognitive impairments in inpatient rehabilitation, and to explore the impact of strategy
training on disability.
Design: Non-randomized two-group intervention pilot study.
Setting: Two inpatient rehabilitation units within an academic health centre.
Participants: Individuals with a primary diagnosis of acute stroke, who were admitted to inpatient
rehabilitation and demonstrated cognitive impairments were included. Individuals with severe aphasia;
dementia; major depressive disorder, bipolar, or psychotic disorder; recent drug or alcohol abuse; and
anticipated length of stay less than five days were excluded.
Intervention: Participants received strategy training or an attention control session in addition to usual
rehabilitation care. Sessions in both groups were 30–40 minutes daily, five days per week, for the duration
of inpatient rehabilitation.
Main outcome measures: We assessed feasibility through participants’ recruitment and retention;
research intervention session number and duration; participants’ comprehension and engagement;
intervention fidelity; and participants’ satisfaction. We assessed disability at study admission, inpatient
rehabilitation discharge, 3 and 6 months using the Functional Independence Measure.
Results: Participants in both groups (5 per group) received the assigned intervention (>92% planned
sessions; >94% fidelity) and completed follow-up testing. Strategy training participants in this small
6 Department of Psychiatry, University of Pittsburgh School of
Medicine, Pittsburgh, PA, USA
7Advanced Center for Intervention and Services Research for
Late Life Mood Disorders, Western Psychiatric Institute and
Clinic, Pittsburgh, PA, USA
Elizabeth R Skidmore, Department of Occupational Therapy,
University of Pittsburgh, 5012 Forbes Tower, Pittsburgh, PA
Skidmore et al.
sample demonstrated significantly less disability at six months (M (SE) = 117 (3)) than attention control
participants (M(SE) = 96 (14); t8 = 7.87, P = 0.02).
Conclusions: It is feasible and acceptable to administer both intervention protocols as an adjunct to
acute inpatient rehabilitation, and strategy training shows promise for reducing disability.
Rehabilitation interventions, cognitive impairment, stroke, strategy training
Received: 9 May 2013; accepted: 3 August 2013
Rehabilitation practitioners routinely employ com-
plex interventions to promote improvements in a
variety of functional and health-related outcomes.
The Medical Research Council defines complex
interventions as ‘interventions that contain several
interacting components (including] the number
and difficulty of behaviors required by those
administering and receiving the intervention, the
number of groups or organizational levels targeted
by the intervention, the number and variability of
outcomes addressed by the intervention, and the
degree of flexibility or tailoring of the intervention
permitted’ (ref. 1, p. 7). Thus, by definition, devel-
oping, evaluating and implementing complex
interventions is challenging. Nonetheless, this pro-
cess is critical to the effective and ethical conduct
The lack of rigour in the development and evalu-
ation of rehabilitation interventions is well-docu-
mented.3 There are a dearth of preliminary studies
that (1) specify the theoretical foundations and
mechanisms of complex interventions and (2) vali-
date intended outcomes.4 As a result, there have
been several premature and costly efficacy and
effectiveness studies (in the form of large-scale ran-
domized controlled trials) that have yielded ambig-
uous findings.4 Furthermore, sparse reporting on
scientific methods (e.g. specification of active
ingredients, manualization of procedures, definition
and measurement of intervention fidelity, and devel-
opment of valid and acceptable control or compari-
son conditions) impedes reproduction and weakens
confidence in the robust nature of intervention in
clinical practice.4–7 To address these concerns, the
Medical Research Council has published revised
guidelines on the development and evaluation of
Our laboratory has been applying these guide-
lines to the development and evaluation of a com-
plex intervention, meta-cognitive strategy training
(hereafter referred to as strategy training),8,9 in an
effort to improve rehabilitation outcomes for adults
with stroke-related cognitive impairments enrolled
in acute inpatient rehabilitation. Individuals who
sustain moderate to severe cognitive impairments
experience significantly greater disability compared
to individuals who sustain minimal or no cognitive
impairments.10,11 Strategy training shows promise
for reducing disability, particularly when adminis-
tered early in recovery. Consistent with the Medical
Research Council Guidelines, we previously
reported the development (i.e. evidence base, theo-
retical model)12 and the feasibility of strategy train-
ing for an adult with cognitive impairments enrolled
in inpatient rehabilitation.13 The current study
expanded our pilot testing to address the feasibility
and acceptability of both strategy training and an
attention control intervention in a small group of
adults with stroke-related cognitive impairments
enrolled in acute inpatient rehabilitation. We also
explored the impact of strategy training on activities
of daily living disability within the first six months
after admission to acute inpatient rehabilitation.
We recruited participants from consecutive admis-
sions to two inpatient rehabilitation units in the same
academic health system over an 18-month time
frame. We obtained informed consent or proxy con-
sent consistent with approved institutional review
board procedures, and screened potential partici-
pants for the following criteria: (1) primary diagno-
sis of acute stroke (within 30 days); (2) admission to
inpatient rehabilitation; (3) impairment of cognitive
Clinical Rehabilitation 28(4)
functions (indicated by a score of 11 or higher on the
Executive Interview);14 (4) absence of severe apha-
sia (indicated by a score of 0 or 1 on the Boston
Diagnostic Aphasia Examination 3rd Edition
Severity Rating Scale);15 (5) absence of pre-stroke
diagnosis of dementia (indicated in the medical
record); (6) absence of current major depressive dis-
order, bipolar or psychotic disorder (indicated by the
Primary Care Evaluation of Mental Disorders);16 (7)
absence of drug and alcohol abuse within three
months of study admission (indicated by the Mini-
International Neuropsychiatric Interview);17 and (8)
anticipated length of stay greater than five days.
Eligible participants were assigned to one of two
intervention groups, strategy training or attention
control. To avoid cross-contamination within unit,
participants on one unit received strategy training,
and participants on the other unit received the atten-
tion control intervention (decided through coin toss).
Participants in both groups engaged in research inter-
vention sessions in addition to their usual inpatient
rehabilitation sessions. The research sessions were
30–40 minutes and were administered daily five days
per week for the duration of the length of stay.
Research sessions were administered according to
manualized procedures by trained occupational ther-
apy personnel who were naïve to the opposing
research intervention protocol (one strategy training
therapist; one attention control therapist). All research
intervention sessions were videotaped and rated for
fidelity to the respective manualized procedures.
The strategy training protocol is described else-
where.13,18,19 In this study, strategy training
addressed four critical ingredients (self-selected
goals, self-evaluation of performance, strategy
development and implementation, and therapeutic
guided discovery) using four steps. Briefly, the
strategy training therapist solicited self-selected
goals from the participants using the Canadian
Occupational Performance Measure (Step 1: Self-
selection of goals).20,21 This measure is a standard
tool used to generate goals for rehabilitation, by
helping participants identify activities of daily liv-
ing that are (1) important to them based on their
‘typical’ routine before the stroke and (2) likely to
be problematic after the stroke. The strategy train-
ing therapist then asked participants to prioritize
these problematic activities and identify the highest
priority activities as a starting point. Once partici-
pants identified the first problematic activity to
address, the strategy training therapist asked partici-
pants to perform the activity and identify barriers to
performance (Step 2: Self-evaluation). Next, the
strategy training therapist taught participants the
‘goal–plan–do–check’ strategy,9 asking participants
to set a goal to address the barriers (i.e. identify a
criterion for performance), develop a plan to address
the goal, do the plan, and check whether the plan
worked or required revising (Step 3: Strategy devel-
opment). This process was repeated iteratively until
the participant’s criterion for the goal was met (and
thus participants moved on to the next activity)
(Step 4: Generalization and transfer). The strategy
training therapist used a therapeutic tool known as
guided discovery,22 guiding participants using
prompting questions, as well as workbooks that aid
the participants in implementing the process.
The attention control protocol was designed to
control for the non-specific effects of strategy train-
ing (i.e. dose, attention). The attention control ther-
apist administered standardized and dose-matched
sessions, using scripted open-ended questions
designed to promote participants’ reflections on
their rehabilitation activities and experiences. In
lieu of strategy training workbook materials, par-
ticipants in the attention control group completed a
daily journal detailing their thoughts and feelings
about their stroke and their rehabilitation, and dis-
cussed these entries during the attention control ses-
sions. We validated the attention control protocol in
the course of this pilot study.
All clinical assessments were administered by
trained and reliable assessors who were masked to
group assignment. We collected demographic (age,
gender, race, ethnicity, education, vocation, and
social support) and medical information (stroke
aetiology and onset, comorbidities, medications)
from the medical record at study admission. We
Skidmore et al.
characterized stroke severity with the National
Institutes of Health Stroke Scale.23
We assessed the feasibility of both research
interventions by examining several indicators. For
both groups, we examined the number of partici-
pants recruited and retained; the number and dura-
tion of research intervention sessions; participants’
comprehension of information; and participants’
engagement in the research intervention sessions.
We rated participants’ understanding of information
using a 3-point scale (1 = minimal understanding,
2 = some understanding, 3 = good understanding).
We rated participants’ engagement in the research
sessions using the Pittsburgh Rehabilitation
Participation Scale, a 6-point valid and reliable
scale assessing effort and motivation during inter-
vention sessions (1 = no engagement, 6 = excellent
engagement).24 Both measures were scored during
each research session by the research therapist.
Mean understanding and engagement scores were
used in data analyses.
We further assessed feasibility by developing and
validating fidelity checklists for both research inter-
ventions, and applying these checklists to assess
fidelity in a random 20% of sessions in each treat-
ment group. We examined two facets of fidelity: (1)
treatment integrity, and (2) treatment differentiation.
To address treatment integrity, independent raters
trained in the respective protocols assessed adher-
ence to specified principles in each protocol (yes,
no), and competence in execution (inadequate, ade-
quate, exceptional). To address treatment differenti-
ation between the two protocols, raters assessed
adherence of both research interventions to the strat-
egy training protocol to determine the degree to
which the strategy training sessions adhered to the
planned protocol, and the degree to which the atten-
tion control sessions did not include elements of the
strategy training protocol. The two protocols were
considered differentiated if adherence ratings were
significantly higher for strategy training sessions
compared to attention control sessions.25
We assessed the acceptability of both research
interventions with the Client Satisfaction
Questionnaire (8-item version)26 at the time of dis-
charge from acute inpatient rehabilitation. Total
scores were computed and dichotomized into two
categories: poor to fair satisfaction (0–23) and mod-
erate to high satisfaction (24–32).
We compared differences in length of stay. We
also collected information on usual rehabilitation
after acute inpatient rehabilitation (setting, disci-
plines, and duration) from the medical record and
through participant interview. Finally, we inter-
viewed members of the clinical rehabilitation team
after the participant was discharged from the hospi-
tal to ascertain whether the research sessions influ-
enced usual rehabilitation care. These data were
gleaned to inform the design of future trials, indicat-
ing whether randomization within unit would be
feasible, or randomization with stratification by unit
would be necessary.
We assessed activities of daily living disability
using the Functional Independence Measure.27 We
administered the Functional Independence Measure
at study admission, discharge (from acute inpatient
rehabilitation), three months after study admission,
and six months after study admission.
To assess feasibility and acceptability, we computed
descriptive statistics and t-tests, as appropriate. To
assess reduction in disability, we analysed data
according to group membership regardless of study
completion. We began by examining relevant base-
line characteristics, testing for baseline differences
between groups, and correlations between signifi-
cant characteristics and the dependent variable
(Functional Independence Measure). Next, we con-
ducted a repeated measures analysis of variance
examining group (strategy training, attention con-
trol) and time (baseline, discharge, three and six
months) as main effects, including the group-by-
Figure 1 illustrates enrollment, allocation and reten-
tion of participants. We assigned 10 participants to
the two intervention groups (Figure 1).
All participants received the allocated interven-
tion and completed follow-up testing. Strategy
Clinical Rehabilitation 28(4)
training participants completed 96% of intended
sessions (48 out of 50), and attention control par-
ticipants completed 92% of intended attention con-
trol sessions (46 out of 50). There were no
statistically significant differences between groups
in the number of research intervention sessions
(strategy training M = 11.2; attention control M =
9.5; t8 = –0.53, P = 0.61), the average duration of
research intervention sessions in minutes (strategy
training M = 37.7; attention control M = 36.8; t8 =
–0.19, P = 0.86), participants’ understanding of
information (strategy training M = 2.2; attention
control M = 2.6; t8 = 0.84, P = 0.43), or partici-
pants’ engagement in research intervention ses-
sions (strategy training M = 4.3; attention control
M = 4.0; t8 = –0.31, P = 0.77).
Sampled strategy training sessions adhered to
94% of manualized procedures (85 out of 90), and
the strategy training therapist demonstrated accept-
able or exceptional competence for 100% of the
completed procedures. Sampled attention control
sessions adhered to 100% of manualized proce-
dures, and the attention control therapist demon-
strated acceptable or exceptional competence for
99% of completed procedures (89 out of 90). With
respect to intervention differentiation, sampled
strategy training sessions adhered to 94% of manu-
alized procedures on the strategy training protocol
(85 out of 90), and sampled attention control ses-
sions did not contain any of the manualized proce-
dures on the strategy training protocol, indicating
good treatment differentiation. Overall, participants
Assessed for eligibility (n=25)
♦Did not meet study criteria (n=13)
Insufficient cognitive impairment (n=9)
Altered consciousness/aphasia (n=2)
Primary diagnosis not stroke (n=2)
♦Withdrew prior to randomization (n=2)
Changed mind about participation (n=1)
Withdrew due to family reasons (n=1)
♦ Excluded from analysis (n=0)
Lost to follow-up (n=0)
Allocated to strategy training (n=5)
♦ Received allocated intervention (n=5)
Lost to follow-up (n=0)
Allocated to attention control (n=5)
♦ Received allocated intervention (n=5)
♦ Excluded from analysis (n=0)
Figure 1. CONSORT flow diagram.
Skidmore et al.
were satisfied with the research intervention ses-
sions, with 100% of participants in each group
reporting moderate to high satisfaction (strategy
training M = 29.5; attention control M = 30.0; t8 =
0.33, P = 0.75).
There were no significant differences in the
length of inpatient rehabilitation stay (strategy train-
ing M = 24.2; attention control M = 20.2; t8 = –0.91,
P = 0.39). The clinical rehabilitation team did not
detect any effects from the research intervention
sessions in usual rehabilitation care. Anecdotally,
interviews of clinical rehabilitation team members
indicated a consistent inability to identify the con-
tent of research intervention sessions or allocation
Participant characteristics are provided in Table 1.
The two groups did not differ, with the exception of
age. Participants in the strategy training group were
significantly younger than participants in the atten-
tion control group. Age was modestly correlated
with six-month Functional Independence Measure
scores (r = –0.43), but the sample was too small to
examine the effect of age on intervention response.
Functional Independence Measure scores by group
and by time are presented in Table 2. The repeated
measures analysis of variance produced a signifi-
cant group*time interaction (F3,24 = 7.53, P =
0.001), as well as a non-significant main effect of
group (F1,8 = 0.99, P = 0.35), and a significant main
effect of time (F3,24 = 82.29, P < 0.001). All statisti-
cal assumptions were met. Post-hoc analyses sug-
gest that the strategy training group demonstrated a
significantly greater reduction in disability between
baseline and the six-month follow-up compared to
Table 1. Participant characteristics.
Strategy training (n = 5) Attention control (n = 5)
Sex, male, n (%)
Age, years, M (SE)
Race, white, n(%)
Stroke onset, days, M (SE)
Stroke type, ischaemic, n (%)
Hemisphere, right, n(%)
Stroke severity NIHSS, M (SE)*
Cognitive status EXIT, M (SE)*
Length of stay, days, M (SE)
Baseline disability, FIM, M (SE)
χ21 = 0.48
t8 = 4.47†
χ21 = 1.11
t8 = –0.12
χ21 = 0.11
χ21 = 1.67
t8 = –1.52
t8 = 1.39
t8 = –0.91
t8 = 0.11
NIHSS, National Institutes of Health Stroke Scale; EXIT, Executive Interview (14-item version); FIM, Functional Independence
*Higher scores = worse performance.
Table 2. Functional Independence Measure scores.
Strategy training (n = 5) Attention control (n = 5)
Baseline to discharge, M (SE)
Baseline to month 3, M (SE)
Baseline to month 3, M (SE)
Clinical Rehabilitation 28(4)
the attention control group (t8 = 7.87, P = 0.02),
despite the fact that both groups improved signifi-
cantly over time. Groups differed by more than 20
points on the Functional Independence Measure at
six months (Figure 2).
Findings suggest that it is feasible to recruit and
retain participants and administer both interven-
tion protocols as an adjunct to acute inpatient reha-
bilitation. The therapists for each protocol
demonstrated acceptable fidelity to the manualized
procedures. Furthermore, we determined that both
the strategy training and the attention control pro-
tocols were credible and acceptable to participants,
as indicated by moderate to high satisfaction scores
in each group. In fact, several participants in both
groups reported anecdotally that the research inter-
vention sessions were a very important part of
their overall inpatient rehabilitation experience.
Finally, strategy training participants in this small
sample demonstrated significantly less disability
at six months than attention control participants.
These findings must be interpreted with caution,
and are not generalizable beyond this small sam-
ple. Nonetheless, these findings are consistent
with previous studies demonstrating the benefits
of strategy training in individuals with chronic
We learned a few lessons that will inform future
clinical trials. First, 60% of consented participants
were ineligible. While this proportion is comparable
to other clinical rehabilitation studies (64–72%),32–
34 it raises significant concerns as to the widespread
generalizability of future studies. The primary rea-
son for exclusion in this study was insufficient cog-
nitive impairment, defined as an Executive
Interview score of 11 or higher. The Executive
Interview is strongly associated with rehabilitation
outcomes,35 and the 11-point cut-off is based on
normative data from healthy older adults.36
However, many individuals, particularly younger
adults, did not meet this criterion despite observed
cognitive impairments. New evidence suggests that
a 3-point cut-off may be more sensitive.37 Using this
new cut-off, we could have reduced the proportion
of excluded participants from 60% to 28%. It
remains unclear whether this change in inclusion
criteria would yield similar results.
Second, our concern that strategy training may
alter usual rehabilitation care (causing cross-con-
tamination effects) was not supported. The clinical
team was unable to correctly identify group assign-
ment, to describe either research intervention, or to
identify the impact of either research intervention
on usual rehabilitation care. Future studies should
randomize within unit, and more formally assess
cross-contamination. This will likely address a
number of the concerning issues that arose in the
current pilot study, including baseline differences in
age, stroke severity and cognitive impairments, as
well as the potential influences of variability within
usual rehabilitation (i.e. length of stay, number of
usual inpatient rehabilitation sessions, duration and
type of home health and outpatient rehabilitation
Future studies should examine mechanisms of
action. We propose that guided discovery is a par-
ticularly potent active ingredient in strategy training
that may promote changes in daily problem-solving
skills, and cognitive functions. Evidence suggests
that guided discovery is effective in stimulating
decision making and problem-solving skills in indi-
viduals with and without cognitive impairments.22,38
Examination of guided discovery and other active
ingredients can be used to distill the intervention
Figure 2. Functional Independence Measure scores.
Skidmore et al.
into its simplest form for maximal clinical scalabil-
ity. For example, it may be that strategy training
protocol in this study could be simplified to empha-
size guided discovery, and de-emphasize other
active ingredients. Further study is required.
Future studies should also examine characteris-
tics of individuals who do and do not benefit from
strategy training in this venue. Potential moderators
of intervention response such as age, stroke location
or severity, and domains and severity of cognitive
impairments may identify subgroups that require
adapted or alternate intervention approaches.10,39
One particularly important subgroup that we
excluded was individuals with severe aphasia due to
the language-dependent nature of the intervention.
Aphasia incidence after stroke ranges from 21% to
38%.40–42 By excluding individuals with aphasia,
we significantly limit the generalizability of the
findings to the population of individuals enrolled in
inpatient stroke rehabilitation. We posit that indi-
viduals with fluent aphasia may be more able to par-
ticipate in and benefit from strategy training than
individuals with non-fluent aphasia. However, this
hypothesis remains untested.
In summary, strategy training is a feasible and
acceptable adjunct to acute inpatient rehabilitation
among adults with stroke-related cognitive impair-
ments. This pilot study provides critical experiences
that can be used to inform future clinical trials
examining the efficacy of strategy training in inpa-
tient stroke rehabilitation.
● A clinical trial of strategy training is feasi-
ble and acceptable in inpatient rehabilita-
tion among individuals with cognitive
impairments after acute stroke.
● Future studies should consider broader
criteria for cognitive impairments and
larger randomized samples to improve
● Future studies should also examine mecha-
nisms, as well as moderators, of interven-
ERS conceived, designed, and implemented the study, as
well as analysed the data, and drafted the manuscript.
The remaining authors contributed to the conceptualiza-
tion of the study, providing expertise on the conceptual-
ization and implementation of the intervention (DRD,
ESG, MBH), selection and assessment of participants
(JTB, MAB, EMW), and clinical trial design (JTB,
MAD, MBH). All authors contributed to the interpreta-
tion of data, and contributed to the revision of the
The authors would like to thank Rachel S MacMillan,
MOT and Courtney M Zon, MOT for their contributions
to the development and validation of the attention control
Conflict of interest
There are no conflicts of interest to disclose.
This work was supported by the National Institutes of
Health (K12 HD055931), the University of Pittsburgh
Medical Center Rehabilitation Institute and the University
of Pittsburgh Office of Research Health Sciences.
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