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research-article2014
CLINICAL
REHABILITATION
Article
Comparison of occupation-based
and impairment-based occupational
therapy for subacute stroke: a
randomized controlled feasibility
study
Clinical Rehabilitation
2015, Vol. 29(8) 752762
The Author(s) 2014
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DOI: 10.1177/0269215514555876
cre.sagepub.com
Abstract
Objective: To compare occupation-based and impairment-based approaches in occupational therapy
and determine the feasibility of patient recruitment and retention.
Design: A multicenter, randomized, controlled pilot trial with a single blind assessor.
Setting: Ten subacute rehabilitation units in Japan.
Participants: Fifty-four patients with subacute stroke.
Interventions: The experimental group used the iPad application, Aid for Decision-making in Occupation
Choice, to establish occupation-based goals, and evaluation and intervention were conducted mainly
through real occupations. The control group was evaluated according to patients generic abilities and
activities of daily living (ADL), and the intervention mainly involved the impairment-based approach.
Main outcome measures: Short Form-36, Functional Independence Measure, Brunnstrom recovery
stages, The Client Satisfaction Questionnaire, and length of hospital stay.
Results: Of the 1465 potential participants, 54 (3%) subacute stroke patients were enrolled over 16
months and 68% (n = 36) were retained to the 2-month assessment: experimental group (n = 16);
control group (n = 21). Although there was no significant intergroup difference for any outcomes, the
experimental group had a small effect size advantage on the Short Form-36 General health (d = 0.42)
and Role emotional (d = 0.43) subscales relative to the control group. A sample of 118 subacute stroke
patients per group would be required for a lager study.
1Department
6Department
Corresponding author:
Kounosuke Tomori, Occupational Therapy, Kanagawa
University of Human Services, Yokosuka, Kanagawa, 2388522, Japan.
Email: adoc.project@gmail.com
753
Tomori et al.
Conclusions: Results suggest that the occupation-based approach has more potential to improve
General health and Role emotional scores on the Short Form-36 than the impairment-based approach.
Further investigation of study protocol with interventions and recruiting is needed prior to a larger trial.
Keywords
Occupational therapy, occupation-based, impairment-based, activities, Aid for Decision-Making in
Occupation Choice
Received: 18 May 2014; accepted: 25 September 2014
Introduction
The World Health Organization1 has recently
focused attention on activities and participation
with the development of the International
Classification of Functioning, Disability and
Health. Occupational therapy associations24 and
researchers58 have emphasized that occupational
therapy evaluation and intervention should always
be based on an occupation (purposeful and meaningful activities for individual and social context)
rather than the impairments or body structure (the
occupation-based approach).
There are various opinions about occupationbased practice, and Zemke9 states three key points
about the occupation-based approach: 1) assessment
includes occupational interviewing and skilled
observation in the most natural context possible, 2)
treatment uses occupation in the most natural context
possible, and 3) goals focus on facilitating engagement in occupation and participation in community
life, rather than solely on reducing impairments in
the persons body structure and function.
However, the occupation-based approach was
seen as more difficult in a medical-based facility.10
Especially, the occupation-based approach with subacute stroke is controversial because occupational
therapy for this stage of stroke needs to maximize the
recovery of motor and cognitive function and prevent the development of secondary impairment.
Although there was substantial evidence that occupational therapy improves body-function and activities
of daily living (ADL),11,12 research has yet to be carried out about the effect of occupation-based
approach for subacute stroke patients. Thus, the
majority of occupational therapists time was clearly
spent using impairment-focused activities.1316
Method
The present study was a multicenter pilot randomized controlled trial with a single blind assessor.
The study was approved by the ethics committee at
the Kanagawa University of Human Services (No.
23-028).
754
The study was conducted in the Kaifukuki (convalescent) rehabilitation wards of 10 subacute
rehabilitation units in Japan.22 Patients for whom
the onset of disabling diseases, including stroke,
traumatic brain injury, other neurological diseases,
and orthopedic diseases such as hip fracture, had
occurred within the previous three months were
eligible for admission to the Kaifukuki rehabilitation wards. The maximal duration of stay following a stroke is 180 days. The duration of
occupational, physical, or speech therapy sessions
was up to three hours per day in total, and the proportion of therapy time was decided according to
the needs of each patient in order to improve ADL
and discharge them.
In order to use the intervention in the current
study, we divided occupational therapy interventions used in the wards into four categories (see
online Appendix): (1) basic function exercises, (2)
simulated occupational practice, (3) real occupational practice using Personal-ADL, and (4) real
occupational practice excluding Personal-ADL.
Based on a preliminary study in Kaifukuki rehabilitation wards (data not shown), (1) and (2) were
conducted to remediate capacities and abilities, and
(3) and (4) were conducted to adapt, educate, or
restore activities.
Participants included patients with hemiparesis,
at the subacute stage of stroke, who were hospitalized in Kaifukuki rehabilitation wards between
August 2012 and November 2013. Participants
were required to meet all of the following criteria:
aged 40; stroke caused by a cerebral infarct or
intracerebral hemorrhage onset; onset of stroke
30 days; no major cognitive deficits (i.e., participants did not have scores 24 on the Mini-Mental
State Examination),23 aphasia, or depression as an
obstacle to daily living; and the patient was
attended to (charged) by a research occupational
therapist who was not involved in study allocation.
In addition, we excluded patients who had cardiac
or progressive disease, were judged by a primary
physician as unable to undergo occupational therapy, or were attended to (charged) by an occupational therapist who did not participate in study. No
formal power calculation was performed because
this was a pilot study.
Tomori et al.
Choice is a useful tool to facilitate the establishment of activity and participation level goals
according to a systematic and flexible strategy.
After setting the activity and participation level
goals, occupational therapists then observed the
participant performing the selected occupations
and assessed occupational performance.
The interventions focused on acquiring occupation through real occupation-based practice (e.g.,
using chopsticks to eat food, cooking, knitting).
During the hospital stay, the majority of the intervention time (more than two-thirds) was allocated
to real occupational practice (both with and excluding Personal-ADL), and as appropriate, the remaining one-third of intervention time was allocated to
basic function exercises and simulated occupational practice (see online Appendix). Physiotherapy
and/or speech therapy was undertaken as usual,
concurrent with occupational therapy.
In the control group, evaluations were focused
on improving the patients impairment (i.e., bodily
functions and structures according to the ICF) and
personal ADL through physical and cognitive testing. The therapists did not use goal-setting tools
such as the Canadian Occupational Performance
Measure25 or Goal Attainment Scaling.26
The interventions focused on restoring capacities (e.g., neuromuscular facilitation, muscle
strength exercises, cognitive training). During the
hospital stay, the majority of the intervention time
(more than two-thirds) was allocated to basic function exercises and simulated occupational practice,
and as appropriate, the remaining one-third of the
intervention time was allocated to real occupational practice (see online Appendix). Physiotherapy
and/or speech therapy practice was undertaken as
usual. This intervention was typical practice for all
occupational therapists that participated in this
study. Thus, in the control group intervention, the
rehabilitation design followed the format of the
ordinary rehabilitation programs offered by the
Kaifukuki wards (data not shown).
For the outcome assessments, we employed the
Short Form-36,27,28 Brunnstrom recovery stages,29,30
and Functional Independence Measure,31 on pre- and
post-interventions (two month period). The Client
Satisfaction Questionnaire32 and duration of stay
755
were assessed at discharge. Assessments were made
by trained occupational therapists or physical therapists that were blinded to patients group
assignment.
The Short Form-36 was used to assess healthrelated quality of life. These scores are standardized to provide a norm-based score with a mean of
50 and standard deviation of 10 (scale range from
0100, with higher scores indicating better health
status).
Brunnstrom recovery stages were used because
the stages reflect underlying motor control based
on clinical assessment of movement quality from
flaccid (palsied) to nearly normal. Higher
Brunnstrom recovery stages indicate better motor
recovery.
The Functional Independence Measure is
widely used to measure activity limitation in terms
of how much help the subject requires in order to
perform basic physical and cognitive activities, via
performance observation. The degree of assistance
required is scored from 1 (total assistance) to 7
(complete independence) and a total score is
expressed by simple summation (the scale ranges
from 18126, with higher scores indicating better
functional status).
The Client Satisfaction Questionnaire contains
8 items. Patients respond to these items using a
4-point Likert scale. Their responses are scored
from 14, and the total possible score ranges from
832. Higher scores indicate greater satisfaction.
We compared baseline characteristics and
between-group outcomes using a two-tailed independent t-test (continuous measures with ordinal
scale data were assessed using the Mann-Whitney
U test) and a chi-square test (for categorical data).
Primary outcomes were assessed two months later.
Intervention effects were tested by examining the
changes in scores (post-test minus baseline) for
each outcome variable. We used a two-tailed independent t-test for between-group comparisons and
a paired t-test (ordinal scale data were analyzed
using Wilcoxons signed rank test) for comparison
of baseline and post-test outcome changes.
We calculated two-tailed 95% confidence intervals and effect sizes (Cohens d), with effect sizes
of 0.3, 0.5, and 0.8 considered small, medium,
756
Results
Figure 1 provides the CONSORT flow diagram
and details of the screening, enrolment, and
delivery of the intervention, whereby 3%
(54/1465) of subacute stroke patients were
enrolled in this study, and 68% (36/54) were
retained up to the two-month assessment. Of the
54 participants, 11 patients in the experimental
group (8 had been discharged early within the
first two months, 2 deteriorated, and 1 was not
suited to the experimental group due to cognitive
dysfunction) and 6 patients in the control group
757
Tomori et al.
Table 1. Patients pre-intervention characteristics.
Characteristics
Experimental
(n = 27)
Control
(n = 27)
Total (N = 54)
68.26
10.90
64.19
10.16
66.22
10.64
22
5
81.5%
18.5%
36
18
66.7%
33.3%
14
12
1
10.45
26.89
48.1%
48.1%
48.1%
6.92
2.55
26
27
1
9.88
26.35
48.1%
50.0%
1.9%
6.95
2.86
0.16
0.02
0.50
0.55
0.17
14
13
51.9%
48.1%
12
15
0
9.30
25.81
44.4%
55.6%
0.0%
7.06
3.10
Discussion
Our results have shown that both occupation-based
and impairment-based approaches to occupational
therapy for inpatients with subacute stroke are
effective in improving health-related quality of life
and recovering physical function and self-care.
Guidetti etal.34 reported that new client-centered
self-care interventions improved ADL, life satisfaction, and caregiver burden for inpatients with
strokes; however, there is no significant difference
from the ordinary intervention. Previously, several
studies demonstrated that occupational therapy
focused on improving Personal-ADL after stroke
and focused body function can improve performance.11,12 Detecting marked differences in the
occupation-based approach relative to ordinary
occupational therapy requires ample studies of the
systematic program to a larger study.
Interestingly, although there were no significant
differences between the groups in any outcomes,
Short Form-36 subscale scores for General health
and Role-emotional significantly increased postintervention in only the experimental group, and
small effects were detected in General health and
Role-emotional subscale scores in the experimental group.
Pre
Short Form-36 V2
Physical
25.0
function
(18.3)
Role
30.1
physical
(35.9)
Bodily pain 65.6
(27.7)
General
48.1
health
(20.6)
Vitality
43.4
(27.9)
Social
57.8
functioning (35.0)
Role
45.3
emotional (39.3)
Mental
54.1
health
(29.5)
Physical
18.8
composite (13.6)
Mental
58.3
composite (11.9)
Role
27.5
composite (20.7)
49.1
(31.8)
45.7
(38.6)
62.5
(30.4)
61.9
(18.7)
54.3
(25.9)
53.1
(36.7)
73.4
(33.2)
59.4
(27.1)
32.0
(16.2)
56.3
(14.7)
32.8
(18.7)
Post
24.1
(17.1)
15.6
(47.2)
3.1
(29.2)
13.8
(18.8)
10.9
(21.2)
4,7
(35.0)
28.1
(40.4)
5.3
(26.5)
13.2
(7.5)
2.0
(14.3)
5.28
(29.15)
33.3
(29.6)
31.8
(34.5)
67.1
(27.3)
56.8
(21.3)
51.5
(18.5)
58.3
(28.3)
46.8
(41.2)
61.7
(20.9)
23.1
(15.2)
62.2
(11.1)
25.5
(20.72)
58.1
(24.8)
36.9
(38.1)
66.0
(24.9)
62.9
(20.0)
62.5
(19.2)
51.2
(35.1)
54.8
(40.5)
64.0
(23.8)
36.6
(12.3)
61.1
(12.2)
23.0
(24.3)
Post
24.8
(29.6)
5.1
(49.8)
1.1
(30.8)
6.1
(17.9)
11.0
(22.7)
7.1
(41.8)
7.9
(52.1)
2.4
(27.6)
13.4
(17.6)
1.0
(9.4)
2.5
(29.2)
0.78
0.32
0.37
0.37
0.91
0.96
0.32
0.22
0.87
0.88
0.33
0.26
0.15
0.88
0.19
0.77
0.13
0.41
0.70
0.11
0.42
0.93
(95% CI) d
Experimental
pre vs post
(95% CI) d
0.93 (16.5 to
15.1)
0.52 (22.2 to
43.4)
0.84 (22.3 to
18.3)
0.22 (4.7 to
20.0)
0.99 (14.9 to
14.8)
0.85 (23.8 to
28.7)
0.21 (11.7 to
52.1)
0.75 (15.3 to
21.2)
0.96 (9.0 to
8.5)
0.80 (8.9 to
6.9)
0.38 (9.8 to
25.4)
Baseline Experimental vs
control
change score
Change P
score
Change Pre
score
Experimental group
(n=16)
mean (SD)
0.70
0.62
0.002
0.70
0.49
0.44
0.04
0.14
0.87
0.65
0.001
0.11
0.13
0.84
0.36
0.43
0.31
1.02
0.23
0.14
0.47
0.86
(Continued)
(38.3 to
11.3)
(27.7 to
17.6)
(12.9 to
15.1)
(14.2 to
2.1)
(21.4 to
0.7)
(11.9 to
26.1)
(31.6 to
15.8)
(14.9 to
10.2)
(21.5 to
5.4)
(3.2 to
5.3)
(10.8 to
15.8)
(95% CI) d
Control
pre vs post
758
Clinical Rehabilitation 29(8)
Pre
Post
0.6
(0.9)
Post
28.9
(3.5)
115.5
(40.8)
15.7
(14.1)
110.6
(14.2)
0.22 0.046
0.77
0.02
0.05 0.046
0.96
0.25
(95% CI) d
(17.37 0.68
to 6.88)
0.16
0.15
0.33
(95% CI) d
Experimental
pre vs post
0.73
Baseline Experimental vs
control
change score
Change P
score
Change Pre
score
93.8
105.9 12.1
94.9
(19.7) (16.1) (9.9)
(23.3)
Client Satisfaction Questionnaire
28.6
(4.2)
Duration of stay
129.3
(40.5)
finger
Brunnstrom
recovery stages
arm
3.8 (1.8) 4.4
(1.7)
Experimental group
(n=16)
mean (SD)
Table 2. (Continued)
0.36
0.21
0.29
(95% CI) d
0.02
0.17
0.01
Control
pre vs post
Tomori et al.
759
760
Shinohara etal.35 reported that occupational
therapy interventions, which is the model of human
occupation based on patient needs for residents
with chronic stroke, tended to improve Short Form36 Role-emotional and General health scores
in a pilot randomized controlled trial. Moreover,
Egan etal.36 reported that community-based occupational therapy, which is a client-centered occupation-based approach guided by the Canadian Model
of Occupational Performance and the Occupational
Performance Process Models, only improved Short
Form-36 Role emotional scores. Our results and
those of previous studies35,36 suggest that Short
Form-36 General health and Role-emotional
scores tended to reflect the efficacy of the occupation-based approach.
Indeed, the definition of occupational therapy is to
promote health and well-being through occupation,
and the primary goal is to enable people to participate
in the ADL.2 Thus, health and daily activities are considered to be closely related to occupational therapy.
In this study, the experimental group evaluation and
intervention centered on identifying activities and
participation that were meaningful to the patient, and
then practicing these activities. We speculate that
improvement areas of Role-emotional and General
health in the experimental group was reasonably
reflected and accepted as a result of the intervention.
Regarding the feasibility of the study design, no
major issues arose with respect to managing the current study, including the multicenter trial and multidisciplinary team approach. Based on the Short
Form-36 General health and Role-emotional
results, a sample of 118 subacute stroke patients per
group would be required for a lager study.
One of the main reasons for exclusion of patients
in the study was cognitive deficit. Our previous
study demonstrated that Mini-Mental State
Examination score of 8 was a suitable cut-off point
for choosing meaningful activities using the Aid
for Decision-making in Occupation Choice tool,
which suggests that the occupation-based approach
could apply to patients with cognitive deficits.
Additional investigation is required to examine
inclusion criteria that do not lead to the rejection of
potential participants with cognitive deficits.
In addition, the requirement for an attending
research occupational therapist is a potentially
Tomori et al.
the individual goal identified by the patient and
therapist in the control group in the Japanese subacute stroke care system.
Finally, the absence of a non-intervention group
is an undeniable possibility of the natural recovery
in pre-post group intervention.
Clinical messages
The occupation-based and impairment-based occupational therapies
have comparable efficacy for patients
with subacute stroke.
Occupation-based therapy has more
potential to improve General health
(d = 0.42) and Role-emotional (d =
0.43) scores on the Short Form-36
than impairment-based therapy.
A sample of 118 subacute stroke
patients per group would be required
for a larger study.
Acknowledgements
The authors thank all the occupational therapists
(Uruma M, Hosokawa H, Taniguchi T, Yamada S, Kato
T, Hirata A, Nakahara K, Miyamoto Y, Nakatsuka S,
Kawakami A, Yoshimura A, Uezu S) that participated
in this study.
Conflict of interest
The authors declare no conflict of interests.
Funding
This work was supported in part by a Grant-in-Aid for
Scientific Research (C) (project no. 24531257 to K
Tomori and project no. 23590610 to R Nagatani) from
the Japan Society for the Promotion of Science.
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