Glove Rehabilitation Application for Stroke Patients

NCT ID: NCT03872466

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2022-04-26

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.

Conditions

Occupational Therapy; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GRASP Intervention

This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system.

Group Type: EXPERIMENTAL

GRASP HEP

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Usual Care Treatment (UCT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Barron Associates, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UVA Outpatient Rehabilitation Clinic

Charlottesville, Virginia, United States

Countries

United States

References

Adams RJ, Ellington AL, Kuccera KA, Leaman H, Smithson C, Patrie JT. Telehealth-Guided Virtual Reality for Recovery of Upper Extremity Function Following Stroke. OTJR (Thorofare N J). 2023 Jul;43(3):446-456. doi: 10.1177/15394492231158375. Epub 2023 Mar 24.

Reference Type: DERIVED

PMID: 36960762 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GRASP

Identifier Type: -

Identifier Source: org_study_id