Glove Rehabilitation Application for Stroke Patients

Not Applicable

Completed

• Conditions: Occupational Therapy; Virtual Reality

• Registration Number: NCT03872466
• Lead Sponsor: Barron Associates, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Study Start: 2020-06-11
• Primary Completion: 2022-04-26
• Study Completion: 2022-04-26
• Results First Submitted: 2023-08-29
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Results First Posted: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Participant has had a right or left hemispheric stroke affecting normal hand function;
2. Participant has sufficient active finger flexion at the MCP joint in at least one finger to be detected by visual observation by a study therapist;
3. Participant has visual acuity with corrective lenses of 20/50 or better;
4. Participant's affected hand fits within sizing available for the glove orthosis;
5. Participant is no longer in an active UE rehabilitation program; and
6. Participant is currently living at a private residence and anticipates remaining at that location for the duration of study participation.

Exclusion Criteria

1. Withholding or withdrawal of consent by the participant;
2. Inability to understand and follow verbal directions;
3. Determination by the Principal Investigator that participation would result in overexertion or significant discomfort or pain;

(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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)	Pre-intervention at Baseline	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.
Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)	Post Intervention at 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)	Post Intervention at 8 weeks	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.
Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)	Pre-intervention at Baseline	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.
Post Intervention Wolf Motor Function Test Time (WMFT-TIME)	Post Intervention at 8 weeks	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.
Pre Intervention Motor Activity Log - Amount (MAL-Amount)	Pre-intervention at Baseline	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.
Post Intervention Motor Activity Log - Amount (MAL-Amount)	Post Intervention at 8 weeks	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.
Pre Intervention Motor Activity Log - How Well (MAL-How Well)	Pre-intervention at Baseline	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.
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)	Pre-intervention at Baseline	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.
Pre Intervention Box and Blocks Test (BBT)	Pre-intervention at Baseline	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.
Post Intervention Box and Blocks Test (BBT)	Post Intervention at 8 weeks	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.
Post Intervention Motor Activity Log - How Well (MAL-How Well)	Post Intervention at 8 weeks	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.

Trial Locations

Locations (1)

UVA Outpatient Rehabilitation Clinic; 🇺🇸 Charlottesville, Virginia, United States