An interventional study of GRASP HEP and Usual Care Treatment (UCT) in Occupational Therapy and Virtual Reality, sponsored by Barron Associates, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Barron Associates, Inc. · Not applicable, Interventional, and Treatment
The University of Virginia (UVA) Director of Neurorehabilitation will lead GRASP randomized, controlled efficacy trials. The study will involve employment of the GRASP system in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment.
Testing will involve employment of the GRASP system (glove orthosis, sensor package, and application software) in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment. This frequency and duration is consistent with previous studies successfully investigating new upper extremity (UE) therapies. The primary outcome of the efficacy study will be change in hand function for a group of participants using the GRASP system versus a control group receiving standard care over the same period.
Participants assigned to the GRASP intervention group will attend five outpatient clinic visits for consent, pre-assessment, and familiarization with the system, followed by an initial home visit and eight weeks (3x per week) of independent at-home practice. In this study period, GRASP intervention group participants will employ the instrumented glove orthosis while performing functional tasks within virtual activities of daily living (ADLs).
Participants in the Usual Care Treatment (UCT) control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT control group participants.
Barron Associates, Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(3) A psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation (Principal Investigator will consult with candidate's personal physician as appropriate); (4) Determination by the Principal Investigator that participation would result in significant agitation or elevated stress; (5) Visual field deficit in either eye that impairs the ability to view the computer monitor; (6) Stiffness or contractures of the muscles, joints, tendons, ligaments, or skin that restricts normal movement; (7) More than mild tone/spasticity (measured on modified Ashworth, 5-point scale); (8) Severe contractures or joint deformities in the fingers; (9) Open wound or infection, severe edema, or excessive swelling which might interfere with wearing the glove; (10) Severe pre-stroke co-morbidities, such as cardiovascular, neurological, orthopedic, or rheumatoid impairments before stroke that may interfere with task performance; (11) Severe sensory deficits from the involved UE; or (12) Hemispatial neglect that impairs the ability to process and perceive visual stimuli provided through the computer monitor.
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
Device: GRASP HEP
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.
Behavioral: Usual Care Treatment (UCT)
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.
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)
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.
Time frame: Pre-intervention at Baseline
Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
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.
Time frame: Post Intervention at 8 weeks
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
The 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.
Time frame: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
The 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.
Time frame: Post Intervention at 8 weeks
Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)
The 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.
Time frame: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Time (WMFT-TIME)
The 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.
Time frame: Post Intervention at 8 weeks
Pre Intervention Box and Blocks Test (BBT)
The 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.
Time frame: Pre-intervention at Baseline
Post Intervention Box and Blocks Test (BBT)
The 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.
Time frame: Post Intervention at 8 weeks
Pre Intervention Motor Activity Log - Amount (MAL-Amount)
The 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.
Time frame: Pre-intervention at Baseline
Post Intervention Motor Activity Log - Amount (MAL-Amount)
The 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.
Time frame: Post Intervention at 8 weeks
Pre Intervention Motor Activity Log - How Well (MAL-How Well)
The 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.
Time frame: Pre-intervention at Baseline
Post Intervention Motor Activity Log - How Well (MAL-How Well)
The 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.
Time frame: Post Intervention at 8 weeks
| Milestone | GRASP Intervention | Control |
|---|---|---|
| Started | 12 | 9 |
| Completed | 9 | 9 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Physician decision | 2 | 0 |
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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) | 42.22 (35.66 to 48.78) | 42.44 (35.89 to 49.00) |
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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) | 52.33 (45.77 to 58.89) | 44.00 (37.44 to 50.56) |
The 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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) | 2.70 (2.20 to 3.19) | 2.67 (2.17 to 3.16) |
The 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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) | 3.42 (2.73 to 4.12) | 2.84 (2.14 to 3.53) |
The 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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Pre Intervention Wolf Motor Function Test Time (WMFT-TIME) | 8.52 (4.49 to 16.17) | 11.01 (5.80 to 20.90) |
The 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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Post Intervention Wolf Motor Function Test Time (WMFT-TIME) | 6.97 (3.67 to 13.24) | 7.46 (3.93 to 14.16) |
The 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.
| blocks | GRASP Intervention | Control |
|---|---|---|
| Pre Intervention Box and Blocks Test (BBT) | 22.89 (15.29 to 34.26) | 12.78 (6.48 to 25.19) |
The 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.
| blocks | GRASP Intervention | Control |
|---|---|---|
| Post Intervention Box and Blocks Test (BBT) | 28.44 (20.85 to 38.81) | 14.44 (7.76 to 26.88) |
The 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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Pre Intervention Motor Activity Log - Amount (MAL-Amount) | 1.33 (0.80 to 1.86) | 1.30 (0.77 to 1.83) |
The 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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Post Intervention Motor Activity Log - Amount (MAL-Amount) | 2.55 (1.84 to 3.25) | 1.18 (0.48 to 1.89) |
The 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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Pre Intervention Motor Activity Log - How Well (MAL-How Well) | 1.35 (0.79 to 1.91) | 1.18 (0.62 to 1.74) |
The 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.
| score on a scale | GRASP Intervention | Control |
|---|---|---|
| Post Intervention Motor Activity Log - How Well (MAL-How Well) | 2.70 (2.06 to 3.34) | 1.20 (0.56 to 1.84) |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GRASP Intervention | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Control | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | GRASP Intervention | Control | Total |
|---|---|---|---|
| Median | 62 (45 to 82) | 60 (34 to 86) | 60 (34 to 86) |
| Sex: Female, Male(Participants) | GRASP Intervention | Control | Total |
|---|---|---|---|
| Female | 6 | 3 | 9 |
| Male | 6 | 6 | 12 |
| Ethnicity (NIH/OMB)(Participants) | GRASP Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 9 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | GRASP Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 9 | 8 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | GRASP Intervention | Control | Total |
|---|---|---|---|
| United States | 12 | 9 | 21 |
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Barron Associates, Inc.