Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke

NCT03741400 | Completed Results FDA Device

• 1 other identifier: 46423
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

Brief Summary

The Virtual Reality Glove for Hand and Arm Rehabilitation (vREHAB) trial is a randomized, controlled, phase 3 trial aiming to evaluate the safety, usability, and efficacy of a virtual reality biofeedback system (Neofect RAPAEL Smart Glove) to promote recovery of distal arm and hand function in the acute and subacute period after stroke, as compared to standard of care therapy. The aims of the study is to demonstrate:

1. 1.the effect of Smart Glove use on functional recovery, in addition to standard of care rehabilitation therapy.
2. 2.the feasibility of increasing the dose of rehabilitation in acute stroke patients with the Smart Glove.
3. 3.the effect of Smart Glove use on quality of life.

Conditions

Stroke, Acute; Cerebral Infarction

Keywords

motor weakness; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Functional Impairment, Jebsen Taylor Hand Function Test

  The change in scores on the Jebsen-Taylor hand function test (JTHFT) from baseline to twelve weeks (in seconds) was compared between treatment groups. The JTHFT is a standardized and objective measure of hand functions commonly used in activities of daily living (ADLs). The test consists of seven subtests separated into fine (JTHFT-Fine) and gross (JTHFT-Gross) motor tasks. Fine motor tasks include writing, simulated page turning, lifting small objects, and simulated feeding. Gross motor tasks include stacking checkers, lifting large light objects, and lifting large heavy objects. The score was calculated as the total number of seconds to perform the tasks, with a lower score indicating better function. Patients who could not complete a task within 90 seconds were assigned a maximum score of 90 seconds for that task. Therefore, the maximum score was 360 sec for the JTHFT-Fine, 270 sec for the JTHFT-Gross, and 630 sec for the JTHFT-Total.

  baseline, 12 weeks

Secondary Outcomes (5)

• Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment

  baseline, 12 weeks

• Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test

  baseline, 24 weeks

• Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test

  baseline, 24 weeks

• Total Dose of Upper Extremity Rehabilitation

  12 weeks

• Self-rated Stroke-related Disability Between Each Treatment Group

  Weeks 12 and 24

Study Arms (2)

Standard Occupational Therapy + Smart Glove

EXPERIMENTAL

Subjects randomized to this arm will be expected to use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.

Device: Neofect RAPAEL Smart Glove

Standard Occupational Therapy

NO INTERVENTION

Subjects in the control arm will undergo standard of care occupational therapy as prescribed by their care team.

Interventions

Neofect RAPAEL Smart Glove DEVICE

The Neofect Rapael Smart Glove is a biofeedback system designed for upper extremity rehabilitation in stroke survivors. It includes a glove-shaped sensor device and a software application.

Standard Occupational Therapy + Smart Glove

Eligibility Criteria

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

You may qualify if:

• a diagnosis of ischemic or hemorrhagic stroke prior to enrollment.
• unilateral hand/arm weakness from stroke with indication for upper limb rehabilitation therapy.
• ability to successfully play 2 out 4 pre-selected test games with the Smart Glove. The test specific games and criteria for passing are as follows:
• Pour the wine (Pronation/Supination): make 5 pours in first 1 minute
• Snow Ball Fight (Wrist Flexion/Extension w/ gravity eliminated): take down 3 objects in first 1 minute
• Scrub the Floor (Wrist Radial/Ulnar deviation w/ gravity eliminated): scrub the floor 5 times in first 1 minute
• Float the Fish (Finger Flexion/Extension): make 50 meters with 3 or less bumps in first 3 minutes

You may not qualify if:

• Age \<18 years
• history of visually provoked seizures
• psychological disorder that could impede participation
• pre-existing neurologic disorder which causes significant deficits in arm/hand function (e.g. Parkinson's disease, peripheral neuropathy, etc.)
• severe receptive aphasia which results in inability to participate with the Smart Glove.
• cognitive impairment which results in inability to participate with the Smart Glove.
• severe pain impeding upper extremity rehabilitation and use of the Smart Glove
• limited life-expectancy which makes it unlikely that patient will be able to complete the 24-week follow-up visit
• any medical or other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.

Sponsors & Collaborators

• Stanford University: lead
• NEOFECT Rehabilitation Solutions: collaborator

Study Sites (4)

Stanford University

Palo Alto, California, 94305, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Intermountain Healthcare

Salt Lake City, Utah, 84103, United States

Location

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Stroke; Cerebral Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Maarten G. Lansberg, MD PhD
• Organization: Professor of Neurology and Neurological Sciences

lansberg@stanford.edu

(650) 723-4448

Study Officials

• Maarten G Lansberg, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor that will be performing the interval assessments will be blinded to treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurology

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: November 14, 2018
• Study Start: October 1, 2018
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Locations

US (3); BE (1)