Trial Outcomes & Findings for Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity (NCT NCT05311384)
NCT ID: NCT05311384
Last Updated: 2025-03-07
Results Overview
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
COMPLETED
NA
10 participants
Pre-treatment
2025-03-07
Participant Flow
Despite the various strategies were used for recruitment such as reaching out to outpatient clinics in our area, posting recruitment flyer in social media pages, attending stroke support groups, including clinicians and rehabilitation professionals of the stroke unit of our institution, and contacting participants from other studies conducted by the authors, the final sample was smaller than anticipated. The initial sample of 14 was reduced to 10 to follow the funding source timeline.
All participants received the same intervention, thus all individuals were assigned to the same group.
Participant milestones
| Measure |
Keys Intervention
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
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Overall Study
STARTED
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10
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Keys Intervention
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
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Overall Study
Uncontrolled health conditions
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2
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity
Baseline characteristics by cohort
| Measure |
Keys Intervention
n=10 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
61.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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10 participants
n=5 Participants
|
|
Type of stroke
Ischemic
|
5 Participants
n=5 Participants
|
|
Type of stroke
Hemorrhagic
|
2 Participants
n=5 Participants
|
|
Type of stroke
Unsure
|
3 Participants
n=5 Participants
|
|
Time since onset
|
26.9 months
n=5 Participants
|
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Affected side
Left
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5 Participants
n=5 Participants
|
|
Affected side
Right
|
5 Participants
n=5 Participants
|
|
Pre-Morbid Handedness
Right
|
8 Participants
n=5 Participants
|
|
Pre-Morbid Handedness
Left
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-treatmentThe MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
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Motor Activity Log (MAL)
Amount of Use (AOU) Scale
|
1 Points
Interval 0.3 to 1.6
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|
Motor Activity Log (MAL)
Quality of Movement (QOM)
|
1.1 Points
Interval 0.3 to 1.5
|
PRIMARY outcome
Timeframe: 4 weeks after starting the intervention (middle of the protocol)The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Motor Activity Log (MAL)
Amount of Use (AOU) Scale
|
3.5 Points
Interval 1.9 to 4.5
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|
Motor Activity Log (MAL)
Quality of Movement (QOM)
|
3.3 Points
Interval 2.0 to 4.4
|
PRIMARY outcome
Timeframe: after the intervention (8 weeks after starting the protocol)The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment.The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity before and after the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Motor Activity Log (MAL)
Amount of Use (AOU)
|
3.9 Points
Interval 2.5 to 4.8
|
|
Motor Activity Log (MAL)
Quality of Movement (QOM)
|
3.4 Points
Interval 1.7 to 4.7
|
PRIMARY outcome
Timeframe: 3 months after the end of the treatment.The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Motor Activity Log (MAL)
Amount of Use (AOU)
|
4.0 Points
Interval 2.8 to 4.8
|
|
Motor Activity Log (MAL)
Quality of Movement
|
3.7 Points
Interval 2.1 to 4.8
|
PRIMARY outcome
Timeframe: Pre-treatmentThe COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
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Canadian Occupational Performance Measure (COPM)
Performance
|
1.9 Score on a scale
Interval 1.0 to 3.0
|
|
Canadian Occupational Performance Measure (COPM)
Satisfaction
|
1.3 Score on a scale
Interval 1.0 to 1.4
|
PRIMARY outcome
Timeframe: 4 weeks after starting the intervention (middle of the protocol)The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
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Canadian Occupational Performance Measure (COPM)
Performance
|
5.5 score on a scale
Interval 3.8 to 7.6
|
|
Canadian Occupational Performance Measure (COPM)
Satisfaction
|
4.7 score on a scale
Interval 1.6 to 6.0
|
PRIMARY outcome
Timeframe: after the intervention (8 weeks after starting the protocol)The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Canadian Occupational Performance Measure (COPM)
Performance
|
6.3 score on a scale
Interval 3.8 to 8.4
|
|
Canadian Occupational Performance Measure (COPM)
Satisfaction
|
6.1 score on a scale
Interval 3.2 to 8.8
|
PRIMARY outcome
Timeframe: 3 months after the end of the treatment.Population: The administration of the COPM was included in the 3 month follow up assessment visit after the study has started. With the delay in having this modification approved by the institutional ethics committee, the the first two participants did not have COPM administered in the follow up visit. Therefore, data from 5 out of the 7 participants in this study are reported here.
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Outcome measures
| Measure |
Keys Intervention
n=5 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
|
Canadian Occupational Performance Measure (COPM)
Performance
|
6.6 score on a scale
Interval 3.0 to 9.2
|
|
Canadian Occupational Performance Measure (COPM)
Satisfaction
|
6.1 score on a scale
Interval 1.4 to 9.4
|
PRIMARY outcome
Timeframe: Pre-treatmentThe WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
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Wolf Motor Function Test (WMFT) - Performance Time
|
5.32 seconds
Interval 3.17 to 10.64
|
PRIMARY outcome
Timeframe: 4 weeks after starting the intervention (middle of the protocol)The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Wolf Motor Function Test (WMFT) - Performance Time
|
5.32 Seconds
Interval 3.17 to 10.64
|
PRIMARY outcome
Timeframe: after the intervention (8 weeks after starting the protocol)The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Wolf Motor Function Test (WMFT) - Performance Time
|
3.82 Seconds
Interval 2.43 to 31.26
|
PRIMARY outcome
Timeframe: Pre-treatmentThe WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Wolf Motor Function Test (WMFT) - Functional Ability Scale
|
3 score on a scale
Interval 2.0 to 3.5
|
PRIMARY outcome
Timeframe: 4 weeks after starting the intervention (middle of the protocol)The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Wolf Motor Function Test (WMFT) - Functional Ability Scale
|
3 score on a scale
Interval 2.0 to 3.5
|
PRIMARY outcome
Timeframe: after the intervention (8 weeks after starting the protocol)The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Wolf Motor Function Test (WMFT) - Functional Ability Scale
|
3 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Pre-treatmentThe SIS is a self-reported measure of disability and quality of life after stroke. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment. The SIS includes 9 domains and each one of them ranges from 0-100, where lower score mean more difficulty performing the task and lower self-perceived recovery. The domains are: 1) Strength, 2) Memory; 3) Mood; 4) Communication; 5) Activities of Daily Living (ADLs)/ Instrumental ADLs (IADLs); 6) Mobility; 7) Hand Function; 8) Participation; and 9) Recovery.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Stroke Impact Scale (SIS)
Strength
|
51.8 score on a scale
Interval 25.0 to 75.0
|
|
Stroke Impact Scale (SIS)
Memory
|
59.8 score on a scale
Interval 38.1 to 85.7
|
|
Stroke Impact Scale (SIS)
Mood
|
64.2 score on a scale
Interval 50.0 to 69.4
|
|
Stroke Impact Scale (SIS)
Communication
|
90.5 score on a scale
Interval 46.4 to 100.0
|
|
Stroke Impact Scale (SIS)
ADLs / IADLs
|
56.8 score on a scale
Interval 55.0 to 90.0
|
|
Stroke Impact Scale (SIS)
Mobility
|
77 score on a scale
Interval 47.2 to 100.0
|
|
Stroke Impact Scale (SIS)
Hand Function
|
36.1 score on a scale
Interval 25.0 to 75.0
|
|
Stroke Impact Scale (SIS)
Participation
|
56.4 score on a scale
Interval 25.0 to 81.3
|
|
Stroke Impact Scale (SIS)
Recovery
|
58.9 score on a scale
Interval 35.0 to 80.0
|
SECONDARY outcome
Timeframe: 4 weeks after starting the intervention (middle of the protocol)The SIS is a self-reported measure of disability and quality of life after stroke. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment. The SIS includes 9 domains and each one of them ranges from 0-100, where lower score mean more difficulty performing the task and lower self-perceived recovery. The domains are: 1) Strength, 2) Memory; 3) Mood; 4) Communication; 5) Activities of Daily Living (ADLs)/ Instrumental ADLs (IADLs); 6) Mobility; 7) Hand Function; 8) Participation; and 9) Recovery.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
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|---|---|
|
Stroke Impact Scale (SIS)
Strength
|
59.8 score on a scale
Interval 31.3 to 87.5
|
|
Stroke Impact Scale (SIS)
Memory
|
63.9 score on a scale
Interval 35.7 to 66.7
|
|
Stroke Impact Scale (SIS)
Mood
|
63.9 score on a scale
Interval 55.6 to 69.4
|
|
Stroke Impact Scale (SIS)
Communication
|
91.8 score on a scale
Interval 60.7 to 100.0
|
|
Stroke Impact Scale (SIS)
ADLs / IADLs
|
70.4 score on a scale
Interval 40.0 to 92.5
|
|
Stroke Impact Scale (SIS)
Mobility
|
79.4 score on a scale
Interval 33.4 to 97.2
|
|
Stroke Impact Scale (SIS)
Hand function
|
60.7 score on a scale
Interval 10.0 to 90.0
|
|
Stroke Impact Scale (SIS)
Participation
|
69.6 score on a scale
Interval 25.0 to 93.8
|
|
Stroke Impact Scale (SIS)
Recovery
|
59.3 score on a scale
Interval 30.0 to 85.0
|
SECONDARY outcome
Timeframe: after the intervention (8 weeks after starting the protocol)The SIS is a self-reported measure of disability and quality of life after stroke. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment. The SIS includes 9 domains and each one of them ranges from 0-100, where lower score mean more difficulty performing the task and lower self-perceived recovery. The domains are: 1) Strength, 2) Memory; 3) Mood; 4) Communication; 5) Activities of Daily Living (ADLs)/ Instrumental ADLs (IADLs); 6) Mobility; 7) Hand Function; 8) Participation; and 9) Recovery.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Stroke Impact Scale (SIS)
Strength
|
65.2 score on a scale
Interval 43.8 to 87.5
|
|
Stroke Impact Scale (SIS)
Memory
|
61.6 score on a scale
Interval 38.1 to 100.0
|
|
Stroke Impact Scale (SIS)
Mood
|
65.5 score on a scale
Interval 58.3 to 69.4
|
|
Stroke Impact Scale (SIS)
Communication
|
90.3 score on a scale
Interval 50.0 to 100.0
|
|
Stroke Impact Scale (SIS)
ADLs / IADLs
|
77.1 score on a scale
Interval 50.0 to 97.5
|
|
Stroke Impact Scale (SIS)
Mobility
|
82.9 score on a scale
Interval 44.4 to 100.0
|
|
Stroke Impact Scale (SIS)
Hand Function
|
65 score on a scale
Interval 30.0 to 90.0
|
|
Stroke Impact Scale (SIS)
Participation
|
75 score on a scale
Interval 43.8 to 100.0
|
|
Stroke Impact Scale (SIS)
Recovery
|
70 score on a scale
Interval 35.0 to 85.0
|
SECONDARY outcome
Timeframe: 3 months after the end of the treatment.The SIS is a self-reported measure of disability and quality of life after stroke. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment. The SIS includes 9 domains and each one of them ranges from 0-100, where lower score mean more difficulty performing the task and lower self-perceived recovery. The domains are: 1) Strength, 2) Memory; 3) Mood; 4) Communication; 5) Activities of Daily Living (ADLs)/ Instrumental ADLs (IADLs); 6) Mobility; 7) Hand Function; 8) Participation; and 9) Recovery.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Stroke Impact Scale (SIS)
Mobility
|
84.1 score on a scale
Interval 66.7 to 100.0
|
|
Stroke Impact Scale (SIS)
Strength
|
65.2 score on a scale
Interval 25.0 to 81.3
|
|
Stroke Impact Scale (SIS)
Memory
|
67.7 score on a scale
Interval 52.4 to 100.0
|
|
Stroke Impact Scale (SIS)
Mood
|
69 score on a scale
Interval 63.9 to 75.0
|
|
Stroke Impact Scale (SIS)
Communication
|
93.4 score on a scale
Interval 60.7 to 100.0
|
|
Stroke Impact Scale (SIS)
ADLs / IADLs
|
81.1 score on a scale
Interval 60.0 to 97.5
|
|
Stroke Impact Scale (SIS)
Hand Function
|
70.7 score on a scale
Interval 30.0 to 100.0
|
|
Stroke Impact Scale (SIS)
Participation
|
76.8 score on a scale
Interval 37.5 to 100.0
|
|
Stroke Impact Scale (SIS)
Recovery
|
76.4 score on a scale
Interval 60.0 to 90.0
|
SECONDARY outcome
Timeframe: Pre-treatmentThe ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (\<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (\>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and in the middle of the treatment.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Zung Self-Rating Depression Scale
|
34.1 score on a scale
Interval 26.0 to 45.0
|
SECONDARY outcome
Timeframe: 4 weeks after starting the intervention (middle of the protocol)The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (\<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (\>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and in the middle of the treatment.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Zung Self-Rating Depression Scale
|
32.1 score on a scale
Interval 25.0 to 49.0
|
SECONDARY outcome
Timeframe: after the intervention (8 weeks after starting the protocol)The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (\<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (\>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and after the treatment.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Zung Self-Rating Depression Scale
|
30.4 score on a scale
Interval 24.0 to 49.0
|
SECONDARY outcome
Timeframe: 3 months after the end of the treatment.The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (\<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (\>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected right after of the treatment and 3 months after the end of the treatment.
Outcome measures
| Measure |
Keys Intervention
n=7 Participants
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.
Keys Constraint-induced Movement Therapy protocol: All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.
|
|---|---|
|
Zung Self-Rating Depression Scale
|
31 score on a scale
Interval 22.0 to 44.0
|
Adverse Events
Keys Intervention
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