Status:
COMPLETED
Glove Rehabilitation Application for Stroke Patients
Lead Sponsor:
Barron Associates, Inc.
Collaborating Sponsors:
University of Virginia
Conditions:
Occupational Therapy
Virtual Reality
Eligibility:
All Genders
18+ years
Phase:
NA
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 session...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03872466
Start Date
June 11 2020
End Date
April 26 2022
Last Update
March 25 2025
Active Locations (1)
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1
UVA Outpatient Rehabilitation Clinic
Charlottesville, Virginia, United States, 22901