Glove Rehabilitation Application for Stroke Patients

NCT03872466 | Completed Results FDA Device

• 1 other identifier: GRASP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Occupational Therapy; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Post Intervention at 8 weeks

Secondary Outcomes (10)

• Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)

  Pre-intervention at Baseline

• Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)

  Post Intervention at 8 weeks

• Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)

  Pre-intervention at Baseline

• Post Intervention Wolf Motor Function Test Time (WMFT-TIME)

  Post Intervention at 8 weeks

• Pre Intervention Box and Blocks Test (BBT)

  Pre-intervention at Baseline

Study Arms (2)

GRASP Intervention

EXPERIMENTAL

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

Device: GRASP HEP

Control

ACTIVE COMPARATOR

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)

Interventions

GRASP HEP 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.

GRASP Intervention

Usual Care Treatment (UCT) 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barron Associates, Inc.: lead
• University of Virginia: collaborator

Study Sites (1)

UVA Outpatient Rehabilitation Clinic

Charlottesville, Virginia, 22901, United States

Location

Related Publications (1)

• 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.

  PMID: 36960762 DERIVED

Results Point of Contact

• Title: Richard Adams
• Organization: Barron Associates, Inc.

adams@bainet.com

4348253435

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator administrating assessments will be blinded to subject group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intervention group performs therapy using the GRASP system for virtual world-based practice. Control group follows a Usual Care Treatment (UCT) regimen.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: June 11, 2020
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)