Trial Outcomes & Findings for Glove Rehabilitation Application for Stroke Patients (NCT NCT03872466)
NCT ID: NCT03872466
Last Updated: 2025-03-25
Results Overview
FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
COMPLETED
NA
21 participants
Pre-intervention at Baseline
2025-03-25
Participant Flow
Participant milestones
| Measure |
GRASP Intervention
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
GRASP Intervention
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Glove Rehabilitation Application for Stroke Patients
Baseline characteristics by cohort
| Measure |
GRASP Intervention
n=12 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
Total
n=21 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
62 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention at BaselineFMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
|
42.22 score on a scale
Interval 35.66 to 48.78
|
42.44 score on a scale
Interval 35.89 to 49.0
|
PRIMARY outcome
Timeframe: Post Intervention at 8 weeksFMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
|
52.33 score on a scale
Interval 45.77 to 58.89
|
44.00 score on a scale
Interval 37.44 to 50.56
|
SECONDARY outcome
Timeframe: Pre-intervention at BaselineThe WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
|
2.70 score on a scale
Interval 2.2 to 3.19
|
2.67 score on a scale
Interval 2.17 to 3.16
|
SECONDARY outcome
Timeframe: Post Intervention at 8 weeksThe WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
|
3.42 score on a scale
Interval 2.73 to 4.12
|
2.84 score on a scale
Interval 2.14 to 3.53
|
SECONDARY outcome
Timeframe: Pre-intervention at BaselineThe WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)
|
8.52 score on a scale
Interval 4.49 to 16.17
|
11.01 score on a scale
Interval 5.8 to 20.9
|
SECONDARY outcome
Timeframe: Post Intervention at 8 weeksThe WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Post Intervention Wolf Motor Function Test Time (WMFT-TIME)
|
6.97 score on a scale
Interval 3.67 to 13.24
|
7.46 score on a scale
Interval 3.93 to 14.16
|
SECONDARY outcome
Timeframe: Pre-intervention at BaselineThe BBT provides a measure of unilateral gross manual dexterity. Subjects are asked to move 2.5 cm wooden cubes from one 8.5 cm tall box to another, as quickly as possible. The BBT score is simply the number of blocks moved in 60 seconds. A patient's WMFT-FA score is thus an integer number if blocks that is greater than or equal to zero. The maximum number of blocks is 150. An increase in BBT score implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Pre Intervention Box and Blocks Test (BBT)
|
22.89 blocks
Interval 15.29 to 34.26
|
12.78 blocks
Interval 6.48 to 25.19
|
SECONDARY outcome
Timeframe: Post Intervention at 8 weeksThe BBT provides a measure of unilateral gross manual dexterity. Subjects are asked to move 2.5 cm wooden cubes from one 8.5 cm tall box to another, as quickly as possible. The BBT score is simply the number of blocks moved in 60 seconds. A patient's WMFT-FA score is thus an integer number if blocks that is greater than or equal to zero. The maximum number of blocks is 150. An increase in BBT score implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Post Intervention Box and Blocks Test (BBT)
|
28.44 blocks
Interval 20.85 to 38.81
|
14.44 blocks
Interval 7.76 to 26.88
|
SECONDARY outcome
Timeframe: Pre-intervention at BaselineThe MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Pre Intervention Motor Activity Log - Amount (MAL-Amount)
|
1.33 score on a scale
Interval 0.8 to 1.86
|
1.30 score on a scale
Interval 0.77 to 1.83
|
SECONDARY outcome
Timeframe: Post Intervention at 8 weeksThe MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Post Intervention Motor Activity Log - Amount (MAL-Amount)
|
2.55 score on a scale
Interval 1.84 to 3.25
|
1.18 score on a scale
Interval 0.48 to 1.89
|
SECONDARY outcome
Timeframe: Pre-intervention at BaselineThe MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Pre Intervention Motor Activity Log - How Well (MAL-How Well)
|
1.35 score on a scale
Interval 0.79 to 1.91
|
1.18 score on a scale
Interval 0.62 to 1.74
|
SECONDARY outcome
Timeframe: Post Intervention at 8 weeksThe MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function.
Outcome measures
| Measure |
GRASP Intervention
n=9 Participants
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
|
Control
n=9 Participants
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants.
Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
|
|---|---|---|
|
Post Intervention Motor Activity Log - How Well (MAL-How Well)
|
2.70 score on a scale
Interval 2.06 to 3.34
|
1.20 score on a scale
Interval 0.56 to 1.84
|
Adverse Events
GRASP Intervention
Control
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