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

• ClinicalTrials.gov Identifier: NCT03741400
• Recruitment Status: Recruiting
• First Posted: November 14, 2018
• Last Update Posted: October 11, 2021
• Sponsor: Stanford University
• Collaborator: NEOFECT Rehabilitation Solutions
• Information provided by (Responsible Party): Maarten Lansberg, Stanford University

Study Description

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. 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.

Condition or disease	Intervention/treatment	Phase
Stroke, Acute; Cerebral Infarction	Device: Neofect RAPAEL Smart Glove	Not Applicable

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 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 are (1) within 30 days from an ischemic or hemorrhagic stroke (with aim for enrollment within 1 week post 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Assessor that will be performing the interval assessments will be blinded to treatment arm.
• Primary Purpose: Treatment
• Official Title: Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke
• Actual Study Start Date: October 1, 2018
• Estimated Primary Completion Date: September 30, 2023
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Improvement in Functional Impairment, Jebsen Taylor Hand Function Test [ Time Frame: 12 weeks ]
   The change in scores on the Jebsen-Taylor hand function test from baseline to twelve weeks (in seconds) will be compared between treatment groups.

Secondary Outcome Measures :

1. Improvement in Functional Impairment, Upper Extremity Fugl-Meyer assessment [ Time Frame: 12 weeks ]
   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.
2. Persistence of treatment effects from 12-24 weeks in Jebsen Taylor hand function test [ Time Frame: 24 weeks ]
   Change in scores in the Jebsen Taylor hand function test between 12 weeks and 24 weeks (in seconds) will be compared between treatment groups.
3. Persistence of treatment effects from 12-24 weeks in Upper Extremity Fugl-Meyer test [ Time Frame: 24 weeks ]
   Change in scores in Upper Extremity Fugl-Meyer [0-66, with higher score meaning better motor function] test between 12 weeks and 24 weeks will be compared between treatment groups.
4. Total dose of upper extremity rehabilitation [ Time Frame: 24 weeks ]
   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.
5. Self-rated stroke-related disability between each treatment group [ Time Frame: 24 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• a diagnosis of ischemic or hemorrhagic stroke within 30 days 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.

Contacts and Locations

Contacts

Contact: Maarten G Lansberg, MD, PhD; (650) 723-4499; lansberg@stanford.edu

Contact: Leonel Lugo, BS; 650-725-9189; lugoleo@stanford.edu

Locations

United States, California

Stanford University; Recruiting

Palo Alto, California, United States, 94305

Contact: Stephanie Kemp 650-723-4481 skemp@stanford.edu

Principal Investigator: Maarten Lansberg, MD, PhD

Sponsors and Collaborators

Stanford University

NEOFECT Rehabilitation Solutions

Investigators

• Principal Investigator: Maarten G Lansberg, MD; Stanford University

More Information

• Responsible Party: Maarten Lansberg, Associate Professor, Neurology, Stanford University
• ClinicalTrials.gov Identifier: NCT03741400
• Other Study ID Numbers: 46423
• First Posted: November 14, 2018
• Last Update Posted: October 11, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Maarten Lansberg, Stanford University:

motor weakness; rehabilitation

Additional relevant MeSH terms:

Stroke; Cerebral Infarction; Infarction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemia; Pathologic Processes; Necrosis; Brain Infarction; Brain Ischemia