Glove Rehabilitation Application for Stroke Patients (GRASP)
Glove Rehabilitation Application for Stroke Patients (GRASP)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Charlottesville, Virginia, United States, 22901
- UVA Outpatient Rehabilitation Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant has had a right or left hemispheric stroke affecting normal hand function;
- 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;
- Participant has visual acuity with corrective lenses of 20/50 or better;
- Participant's affected hand fits within sizing available for the glove orthosis;
- Participant is no longer in an active UE rehabilitation program; and
- Participant is currently living at a private residence and anticipates remaining at that location for the duration of study participation.
Exclusion Criteria:
- Withholding or withdrawal of consent by the participant;
- Inability to understand and follow verbal directions;
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: GRASP Intervention
This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.
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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.
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Active Comparator: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
Time Frame: 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.
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Pre-intervention at Baseline
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Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
Time Frame: 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.
|
Post Intervention at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
Time Frame: 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 at Baseline
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Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
Time Frame: Post Intervention at 8 weeks
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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. |
Post Intervention at 8 weeks
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Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)
Time Frame: Pre-intervention at Baseline
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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.
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Pre-intervention at Baseline
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Post Intervention Wolf Motor Function Test Time (WMFT-TIME)
Time Frame: 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.
|
Post Intervention at 8 weeks
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Pre Intervention Box and Blocks Test (BBT)
Time Frame: Pre-intervention at Baseline
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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.
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Pre-intervention at Baseline
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Post Intervention Box and Blocks Test (BBT)
Time Frame: 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.
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Post Intervention at 8 weeks
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Pre Intervention Motor Activity Log - Amount (MAL-Amount)
Time Frame: Pre-intervention at Baseline
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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.
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Pre-intervention at Baseline
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Post Intervention Motor Activity Log - Amount (MAL-Amount)
Time Frame: Post Intervention at 8 weeks
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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 at 8 weeks
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Pre Intervention Motor Activity Log - How Well (MAL-How Well)
Time Frame: 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 at Baseline
|
|
Post Intervention Motor Activity Log - How Well (MAL-How Well)
Time Frame: 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.
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Post Intervention at 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GRASP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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