Trial Outcomes & Findings for CO-OPerative Training for Stroke Rehabilitation (NCT NCT02755805)
NCT ID: NCT02755805
Last Updated: 2017-11-06
Results Overview
Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point.
COMPLETED
NA
30 participants
Baseline, rehabilitation discharge, month 3, month 6
2017-11-06
Participant Flow
Recruitment period: July 2009 to June 2012. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.
Excluded (n=30): * Insufficient cognitive impairment (n=15) * Mood/psychotic disorder (n=5) * Aphasia (n=3) * Recent drug/alcohol abuse (n=2) * Primary diagnosis not stroke (n=2) Withdrew prior to randomization (n=3) * Changed mind (n=1) * Family reasons (n=1) * Unexpected discharge (n=1)
Participant milestones
| Measure |
CO-OP
Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP
|
Attention Control
The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
CO-OP
Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP
|
Attention Control
The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Refused assessments
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
CO-OPerative Training for Stroke Rehabilitation
Baseline characteristics by cohort
| Measure |
CO-OP
n=15 Participants
Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP
|
Attention Control
n=15 Participants
The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.87 years
STANDARD_DEVIATION 16.59 • n=5 Participants
|
71.80 years
STANDARD_DEVIATION 13.19 • n=7 Participants
|
67.33 years
STANDARD_DEVIATION 15.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Stroke onset
|
16.80 days
STANDARD_DEVIATION 15.58 • n=5 Participants
|
18.47 days
STANDARD_DEVIATION 21.29 • n=7 Participants
|
17.63 days
STANDARD_DEVIATION 18.35 • n=5 Participants
|
|
Stroke type
ischemic
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Stroke type
hemorrhagic
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Hemisphere
right
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Hemisphere
left
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Stroke severity, NIHSS (National Institutes of Health Stroke Scale)
|
8.87 units on a scale
STANDARD_DEVIATION 2.77 • n=5 Participants
|
5.87 units on a scale
STANDARD_DEVIATION 2.72 • n=7 Participants
|
7.37 units on a scale
STANDARD_DEVIATION 3.10 • n=5 Participants
|
|
Medical burden, CIRS (Cumulative Illness Rating Scale)
|
2.37 units on a scale
STANDARD_DEVIATION .47 • n=5 Participants
|
2.36 units on a scale
STANDARD_DEVIATION .57 • n=7 Participants
|
2.37 units on a scale
STANDARD_DEVIATION 0.53 • n=5 Participants
|
|
Cognitive status, EXIT (Quick Executive Interview)
|
8.13 units on a scale
STANDARD_DEVIATION 3.00 • n=5 Participants
|
9.31 units on a scale
STANDARD_DEVIATION 3.54 • n=7 Participants
|
8.72 units on a scale
STANDARD_DEVIATION 3.28 • n=5 Participants
|
|
Communication status, BDAE (Boston Diagnositic Aphasia Examination Severity Index)
|
4.27 units on a scale
STANDARD_DEVIATION 1.03 • n=5 Participants
|
4.67 units on a scale
STANDARD_DEVIATION .62 • n=7 Participants
|
4.47 units on a scale
STANDARD_DEVIATION 0.86 • n=5 Participants
|
|
Functional Independence Measure
|
65.27 units on a scale
STANDARD_DEVIATION 10.85 • n=5 Participants
|
62.60 units on a scale
STANDARD_DEVIATION 16.56 • n=7 Participants
|
63.93 units on a scale
STANDARD_DEVIATION 13.82 • n=5 Participants
|
|
Inhibition, CWI (Color Word Interference)
|
4.85 units on a scale
STANDARD_DEVIATION 4.10 • n=5 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 2.98 • n=7 Participants
|
4.39 units on a scale
STANDARD_DEVIATION 3.50 • n=5 Participants
|
|
Cognitive flexibility, CWI (Color Word Interference)
|
3.69 units on a scale
STANDARD_DEVIATION 2.36 • n=5 Participants
|
2.73 units on a scale
STANDARD_DEVIATION 2.34 • n=7 Participants
|
3.18 units on a scale
STANDARD_DEVIATION 2.36 • n=5 Participants
|
|
Depressive symptoms, HamD (Hamilton Rating Scale for Depression)
|
6.71 units on a scale
STANDARD_DEVIATION 4.36 • n=5 Participants
|
6.75 units on a scale
STANDARD_DEVIATION 4.53 • n=7 Participants
|
6.73 units on a scale
STANDARD_DEVIATION 4.35 • n=5 Participants
|
|
Apathy, AES
|
25.79 units on a scale
STANDARD_DEVIATION 7.62 • n=5 Participants
|
25.18 units on a scale
STANDARD_DEVIATION 4.40 • n=7 Participants
|
25.52 units on a scale
STANDARD_DEVIATION 6.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, rehabilitation discharge, month 3, month 6Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point.
Outcome measures
| Measure |
CO-OP
n=15 Participants
Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP
|
Attention Control
n=15 Participants
The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control
|
|---|---|---|
|
Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Baseline Scores
|
65.27 units on a scale
Standard Error 2.80
|
62.60 units on a scale
Standard Error 4.28
|
|
Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Discharge Scores
|
86.80 units on a scale
Standard Error 3.27
|
80.53 units on a scale
Standard Error 5.73
|
|
Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Month 3
|
109.69 units on a scale
Standard Error 2.61
|
91.23 units on a scale
Standard Error 7.48
|
|
Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Month 6
|
113.31 units on a scale
Standard Error 2.48
|
95.27 units on a scale
Standard Error 7.60
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsDifference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models. The Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point.
Outcome measures
| Measure |
CO-OP
n=15 Participants
Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP
|
Attention Control
n=15 Participants
The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control
|
|---|---|---|
|
Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)
Baseline Scores
|
4.85 units on a scale
Standard Error 1.14
|
4.00 units on a scale
Standard Error 0.77
|
|
Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)
Month 3 Scores
|
8.73 units on a scale
Standard Error 3.00
|
4.40 units on a scale
Standard Error 1.37
|
|
Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)
Month 6 Scores
|
8.20 units on a scale
Standard Error 1.13
|
3.67 units on a scale
Standard Error 1.11
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsDifference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models. The Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point.
Outcome measures
| Measure |
CO-OP
n=15 Participants
Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP
|
Attention Control
n=15 Participants
The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control
|
|---|---|---|
|
Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
Baseline Scores
|
3.69 units on a scale
Standard Error 0.65
|
2.73 units on a scale
Standard Error 0.61
|
|
Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
Month 3 Scores
|
8.82 units on a scale
Standard Error 0.81
|
3.00 units on a scale
Standard Error 0.93
|
|
Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
Month 6 Scores
|
8.20 units on a scale
Standard Error 0.73
|
2.78 units on a scale
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsDifference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models. The Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point.
Outcome measures
| Measure |
CO-OP
n=15 Participants
Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP
|
Attention Control
n=15 Participants
The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control
|
|---|---|---|
|
Differences in Apathy Symptoms Between Groups Over Time
Baseline Scores
|
25.79 units on a scale
Standard Error 2.04
|
25.18 units on a scale
Standard Error 1.32
|
|
Differences in Apathy Symptoms Between Groups Over Time
Month 3 Scores
|
25.18 units on a scale
Standard Error 1.65
|
34.13 units on a scale
Standard Error 4.70
|
|
Differences in Apathy Symptoms Between Groups Over Time
Month 6 Scores
|
21.38 units on a scale
Standard Error 1.34
|
29.00 units on a scale
Standard Error 4.82
|
Adverse Events
CO-OP
Attention Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth R. Skidmore, PhD, OTR/L, FAOTA
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place