Clinical trial NCT03872466: Glove Rehabilitation Application for Stroke Patients
Official title: Glove Rehabilitation Application for Stroke Patients (GRASP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Therapy
Virtual Reality
Lead sponsor: Barron Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
First posted: 2019-03-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group performs therapy using the GRASP system for virtual world-based practice.

Control group follows a Usual Care Treatment (UCT) regimen.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
timeFrame: Pre-intervention at Baseline
measure: Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
timeFrame: Post Intervention at 8 weeks
Secondary outcomes:
measure: Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
timeFrame: Pre-intervention at Baseline
measure: Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
timeFrame: Post Intervention at 8 weeks
measure: Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)
timeFrame: Pre-intervention at Baseline
measure: Post Intervention Wolf Motor Function Test Time (WMFT-TIME)
timeFrame: Post Intervention at 8 weeks
measure: Pre Intervention Box and Blocks Test (BBT)
timeFrame: Pre-intervention at Baseline
measure: Post Intervention Box and Blocks Test (BBT)
timeFrame: Post Intervention at 8 weeks
measure: Pre Intervention Motor Activity Log - Amount (MAL-Amount)
timeFrame: Pre-intervention at Baseline
measure: Post Intervention Motor Activity Log - Amount (MAL-Amount)
timeFrame: Post Intervention at 8 weeks
measure: Pre Intervention Motor Activity Log - How Well (MAL-How Well)
timeFrame: Pre-intervention at Baseline
measure: Post Intervention Motor Activity Log - How Well (MAL-How Well)
timeFrame: Post Intervention at 8 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Outpatient Rehabilitation Clinic
state: Virginia
Study officials:
References: