Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke (vREHAB)

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

Study Overview

• Status: Completed
• Conditions: Cerebral Infarction; Stroke, Acute
• Intervention / Treatment: Device: Neofect RAPAEL Smart Glove

Detailed Description

The Neofect Smart Glove is a commercially available, non-invasive biofeedback based system for distal upper extremity rehabilitation. The Smart Glove is very lightweight and allows for easy movement of all distal upper extremity joints. It consists of a glove-shaped sensor device and a software application which can be used with either a large screen or a portable tablet. The system includes multiple Activities of Daily Living (ADL)-based training games, and the system tracks the motion and posture of the wearer's distal limb as they participate. Games can be selected to focus on certain movements (such as forearm pronation/supination, wrist flexion/extension, finger flexion/extension, etc.) based on the needs of the wearer. The software includes a smart learning algorithm, in which the computer automatically adjusts to the optimal level of difficulty to balance challenge and motivation. After initial set-up, the device requires no therapist supervision to use.

Patients will be eligible for the study if they have had an ischemic or hemorrhagic stroke and (2) have impaired arm/hand function secondary to the stroke (see below for specific inclusion and exclusion criteria). We will recruit eligible patients from acute care hospitals, acute rehabilitation units, and outpatient facilities. Enrolled patients will be randomized (1:1 ratio) to standard rehabilitation therapy versus standard rehabilitation therapy plus Smart Glove use. All patients will be allowed to participate in any scheduled outpatient rehabilitation during the study.

The study consists of a 12-week intervention period and a 12-week follow-up period. During the 12-week intervention period all patients will receive their usual rehabilitation therapy, with their therapists documenting rehabilitation dose in a journal provided at the start of the study. In addition, subjects randomized to the Smart Glove therapy arm will be provided with a Smart Glove system, which includes the glove and tablet. Subjects will be instructed to use the system for at least one session per day for 5 days per week during the 12-week intervention period. Participants will present for in-person visits on weeks 6, 12, and 24 for blinded assessments by study coordinators. At the completion of the intervention period, subjects will return the Smart Glove and subjects in both arms of the study will only receive usual care during the 12-week follow-up period. Subjects will have a final assessment at week 24 (12 weeks after completing the intervention) to assess for persistence of effect.

All efficacy analyses are analyzed under the intention to treat principle. The primary efficacy outcome is the change in score on the Jebsen Taylor Hand Test between baseline and week 12. Secondary efficacy endpoints are changes in scores on the upper extremity Fugl-Meyer Scale, Stroke Impact Scale, and total dose of rehabilitation received during the 24-week intervention period. Persistence of the treatment effect will be tested by comparing changes in scores on the Jebsen Taylor Hand Test and Fugl-Meyer upper extremity score at 24 weeks between treatment groups

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven
• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • Intermountain Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Occupational Therapy + Smart Glove; 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; 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.
No Intervention: Standard Occupational Therapy; Subjects in the control arm will undergo standard of care occupational therapy as prescribed by their care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment	The change in scores on the Upper Extremity Fugl-Meyer [0-66, with higher score meaning better motor function] test from baseline to twelve weeks will be compared between treatment groups. The test measures reflex activity, selective movement, and coordination of the hand, wrist, forearm, elbow, and shoulder.	baseline, 12 weeks
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test	The change in scores on the Jebsen-Taylor hand function test from baseline to twenty-four 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, 24 weeks
Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test	Change in scores in Upper Extremity Fugl-Meyer [0-66, with higher score meaning better motor function] test between baseline and 24 weeks will be compared between treatment groups. The test measures reflex activity, selective movement, and coordination of the hand, wrist, forearm, elbow, and shoulder.	baseline, 24 weeks
Total Dose of Upper Extremity Rehabilitation	Total dose (minutes) of all upper extremity rehabilitation therapy, including Smart Glove therapy, received during the 12-week intervention period will be compared between treatment groups.	12 weeks
Self-rated Stroke-related Disability Between Each Treatment Group	Domain scores (0-100, with 100 being better self-rated function in each of: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation) on the Stroke Impact Scale will be compared between treatment groups at 12 weeks and at 24 weeks.	Weeks 12 and 24

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: NEOFECT Rehabilitation Solutions
• Investigators: Principal Investigator: Maarten G Lansberg, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; motor weakness
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Brain Infarction; Infarction; Stroke; Cerebral Infarction
• Other Study ID Numbers: 46423

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes