Trial Outcomes & Findings for Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke (NCT NCT01309165)
NCT ID: NCT01309165
Last Updated: 2019-02-08
Results Overview
The Performance Quality Rating Scale (PQRS) rates performance on a 10-point scale, with a score of 1 indicating "can't do the skill at all" and 10 indicating "does the skill very well". Inter-rater reliability in the stroke population has been estimated at 0.71 (ICC). An independent observer rates performances from video recorded trials of each skill at all assessment points. Data reported are the average of participants' trained and untrained change scores e.g. Time 2 minus Time 1 and Time 3 minus Time 1. Therapist logs and institutional patient records were reviewed to establish which self-selected activities were trained during the occupational rehabilitation program. A self-selected activity was considered trained if there was any indication of practicing all or part of it or any and indication of discussions or education concerning the activity. If no evidence of training was found it was considered untrained.
COMPLETED
NA
35 participants
A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)
2019-02-08
Participant Flow
Participant milestones
| Measure |
CO-OP
CO-OP: CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10-session intervention format. The client and the therapist work together, using the Canadian Occupational Performance Measure (COPM), to select 3 skills and establish baseline skill performance. In the second meeting, when CO-OP actually begins, the approach is introduced to the client and the global cognitive strategy (GOAL-PLAN-DO-CHECK) is learned. In all subsequent sessions this strategy is used as the main problem-solving framework to facilitate skill acquisition.Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
|
Standard Occupational Therapy
Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
|
Overall Study
Received Allocated Intervention
|
16
|
14
|
|
Overall Study
Included in Primary Analysis
|
14
|
12
|
|
Overall Study
COMPLETED
|
13
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
CO-OP
CO-OP: CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10-session intervention format. The client and the therapist work together, using the Canadian Occupational Performance Measure (COPM), to select 3 skills and establish baseline skill performance. In the second meeting, when CO-OP actually begins, the approach is introduced to the client and the global cognitive strategy (GOAL-PLAN-DO-CHECK) is learned. In all subsequent sessions this strategy is used as the main problem-solving framework to facilitate skill acquisition.Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
|
Standard Occupational Therapy
Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Return to work
|
1
|
2
|
|
Overall Study
Left country
|
0
|
1
|
|
Overall Study
No transportation
|
0
|
1
|
|
Overall Study
Admitted to hospital for second stroke
|
1
|
0
|
Baseline Characteristics
Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke
Baseline characteristics by cohort
| Measure |
CO-OP
n=19 Participants
CO-OP: CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10-session intervention format. The client and the therapist work together, using the Canadian Occupational Performance Measure (COPM), to select 3 skills and establish baseline skill performance. In the second meeting, when CO-OP actually begins, the approach is introduced to the client and the global cognitive strategy (GOAL-PLAN-DO-CHECK) is learned. In all subsequent sessions this strategy is used as the main problem-solving framework to facilitate skill acquisition.Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
|
Standard Occupational Therapy
n=16 Participants
Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
|
Total
n=35 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 14 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 14 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)The Performance Quality Rating Scale (PQRS) rates performance on a 10-point scale, with a score of 1 indicating "can't do the skill at all" and 10 indicating "does the skill very well". Inter-rater reliability in the stroke population has been estimated at 0.71 (ICC). An independent observer rates performances from video recorded trials of each skill at all assessment points. Data reported are the average of participants' trained and untrained change scores e.g. Time 2 minus Time 1 and Time 3 minus Time 1. Therapist logs and institutional patient records were reviewed to establish which self-selected activities were trained during the occupational rehabilitation program. A self-selected activity was considered trained if there was any indication of practicing all or part of it or any and indication of discussions or education concerning the activity. If no evidence of training was found it was considered untrained.
Outcome measures
| Measure |
CO-OP
n=14 Participants
CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10 one-hour sessions intervention format. Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
|
Standard Occupational Therapy
n=12 Participants
Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
|
|---|---|---|
|
Change From Baseline in Performance Quality Rating Scale (PQRS)
Time 3 - 1 Mean Change - Trained
|
4.5 units on a scale
Standard Deviation 1.7
|
1.5 units on a scale
Standard Deviation 2.2
|
|
Change From Baseline in Performance Quality Rating Scale (PQRS)
Time 2 - 1 Mean Change - Trained
|
2.9 units on a scale
Standard Deviation 1.4
|
1.8 units on a scale
Standard Deviation 2.9
|
|
Change From Baseline in Performance Quality Rating Scale (PQRS)
Time 2 - 1 Mean Change - Untrained
|
2.9 units on a scale
Standard Deviation 1.4
|
0.5 units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Performance Quality Rating Scale (PQRS)
Time 3 - 1 Mean Change - Untrained
|
3.6 units on a scale
Standard Deviation 2.3
|
1.5 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)The Canadian Occupational Performance Measure (COPM) is a standardized instrument for eliciting performance issues from the client perspective, and for capturing perceived changes in performance over time.The COPM will be used to elicit participant-selected goals. It will also be used to rate self-perceived performance and performance satisfaction for each goal. Scores range from 1 to 10 (higher is better). Data reported are the average of participants' trained and untrained change scores e.g. Time 2 minus Time 1 and Time 3 minus Time 1. Therapist logs and institutional patient records were reviewed to establish which self-selected activities were trained during the occupational rehabilitation program. A self-selected activity was considered trained if there was any indication of practicing all or part of it or any and indication of discussions or education concerning the activity. If no evidence of training was found it was considered untrained.
Outcome measures
| Measure |
CO-OP
n=14 Participants
CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10 one-hour sessions intervention format. Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
|
Standard Occupational Therapy
n=12 Participants
Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
|
|---|---|---|
|
Change From Baseline in Canadian Occupational Performance Measure (COPM)
Time 2-1 Mean Change Score - Performance - Trained
|
1.5 units on a scale
Standard Deviation 3
|
2.3 units on a scale
Standard Deviation 2.1
|
|
Change From Baseline in Canadian Occupational Performance Measure (COPM)
Time 3-1 Mean Change Score - Performance - Trained
|
2.9 units on a scale
Standard Deviation 1.8
|
2.3 units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Canadian Occupational Performance Measure (COPM)
Time 2-1 Mean Change Score - Performance-Untrained
|
1.3 units on a scale
Standard Deviation 3.1
|
1.9 units on a scale
Standard Deviation 2.3
|
|
Change From Baseline in Canadian Occupational Performance Measure (COPM)
Time 3-1 Mean Change Score - Performance-Untrained
|
3.1 units on a scale
Standard Deviation 2.7
|
2.4 units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Canadian Occupational Performance Measure (COPM)
Time 2-1 Mean Change Score - Satisfaction- Trained
|
1.9 units on a scale
Standard Deviation 2.8
|
1.8 units on a scale
Standard Deviation 2.3
|
|
Change From Baseline in Canadian Occupational Performance Measure (COPM)
Time 3-1 Mean Change Score - Satisfaction- Trained
|
3.2 units on a scale
Standard Deviation 1.8
|
3.7 units on a scale
Standard Deviation 3.3
|
|
Change From Baseline in Canadian Occupational Performance Measure (COPM)
Time 2-1 Mean Change Score- Satisfaction-Untrained
|
1.5 units on a scale
Standard Deviation 3.3
|
1.7 units on a scale
Standard Deviation 2.1
|
|
Change From Baseline in Canadian Occupational Performance Measure (COPM)
Time 3-1 Mean Change Score- Satisfaction-Untrained
|
3.2 units on a scale
Standard Deviation 3
|
2.8 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)The Stroke Impact Scale (SIS) is a stroke-specific health status measure. The scale is comprised of nine domains, of which we are using one, the Participation Domain. Scores range from 0-100 (higher is better).
Outcome measures
| Measure |
CO-OP
n=14 Participants
CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10 one-hour sessions intervention format. Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
|
Standard Occupational Therapy
n=12 Participants
Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
|
|---|---|---|
|
Change From Baseline in Stroke Impact Scale (SIS) Participation Domain
Time 2 Mean Score
|
47.9 units on a scale
Standard Deviation 16.8
|
54.6 units on a scale
Standard Deviation 13.7
|
|
Change From Baseline in Stroke Impact Scale (SIS) Participation Domain
Time 3 Mean Score
|
56.6 units on a scale
Standard Deviation 16.7
|
56.9 units on a scale
Standard Deviation 13.3
|
|
Change From Baseline in Stroke Impact Scale (SIS) Participation Domain
Time 3-1 Mean Change Score
|
8.0 units on a scale
Standard Deviation 9.9
|
1.9 units on a scale
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: A) Time 2- post-intervention (approx. 6 weeks from baseline), B) Time 3- 3 month follow-up (approx. 17 weeks from baseline)The Activity Card Sort (ACS) is a client-centred interview based instrument that identifies participation in instrumental, social, and high- and low- demand physical leisure activities. A sorting methodology is used to identify whether or not the person performed the activity before their stroke and the person identifies the activities that are most important to them. The properties of ACS have been tested in various populations and there is evidence for internal consistency, construct, concurrent, and discriminant validity. Data reported are the average of participants' trained and untrained change scores e.g. Time 2 minus Time 1 and Time 3 minus Time 1.
Outcome measures
| Measure |
CO-OP
n=14 Participants
CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10 one-hour sessions intervention format. Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
|
Standard Occupational Therapy
n=12 Participants
Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
Standard Occupational Therapy: Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
|
|---|---|---|
|
Change From Baseline in Activity Card Sort (ACS)
Time 2 Mean Total
|
34.4 units on a scale
Standard Deviation 12.7
|
28.1 units on a scale
Standard Deviation 11.6
|
|
Change From Baseline in Activity Card Sort (ACS)
Time 3 Mean Total
|
37.4 units on a scale
Standard Deviation 13.0
|
29.6 units on a scale
Standard Deviation 7.2
|
Adverse Events
CO-OP
Standard Occupational Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place