Effects of Virtual Reality Based Rehabilitation in Acute Stroke Patients in an Inpatient Rehab Setting

The Comparison Study of Virtual Reality Rehabilitation With Standard Occupational Therapy Versus Standard Occupational Therapy

To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their hand in supplementation with conventional occupational therapy to assess whether it improves motor function and speed recovery during inpatient rehabilitation versus conventional occupational therapy alone. Also, what impact does this have on quality of life.

Study Overview

• Status: Withdrawn
• Conditions: Hemiplegia; Stroke Syndrome
• Intervention / Treatment: Device: Rapael

Detailed Description

The American Stroke Association states that stroke is 5th leading cause of death in the United States and one of the leading causes of disability and loss of motor function. Approximately 80% of stroke survivors have upper extremity limitations where the distal upper extremity motor function is severely affected and is the last body part to recover. Restoration of arm function is essential to regaining activities of daily living (ADL) such as holding objects like utensils, turning a doorknob, writing or telephone use. Literature search shows that intensive and repetitive training may be necessary to modify neural organization and recover functional motor skills. Along with traditional rehabilitation methods, virtual reality (VR) based rehabilitation has emerged in recent years. VR-based rehabilitation is more intensive, of longer duration and more repetitive. Using VR rehabilitation, repetitive dull exercises can turn into a more challenging and motivating tasks such as games. Moreover, VR-based rehabilitation can provide a quantitative measure of the rehabilitation progress.

The investigators propose a study comparing conventional occupational services versus virtual reality-based rehabilitation intervention for participants during acute phase of stroke in the inpatient rehabilitation setting. The investigators hypothesize that by using VRA, will see a significant increase in the overall motor function, shorter hospital course and improved quality of life for the participants.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Burke Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Minimum age of 18 years' old
• Unilateral upper extremity functional deficits after stroke
• First ever clinical diagnosis of stroke in the dominant hemisphere
• Diagnosis of ischemic or hemorrhagic stroke with unilateral paresis of dominant hand

Exclusion Criteria:

• Age less than 18 years' old
• Cognitive impairment resulting in inability to participate
• Severe aphasia resulting in inability to communicate to give consent or participate.

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
No Intervention: Standard occupational therapy; This group will receiving standard occupational therapy for the treatment of acute stroke.
Experimental: SOT plus VR Rapael; This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.	Device: Rapael; This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test	Scores on the Wolf Motor Function test measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire	Scores of Michigan Hand Outcome Questionnaire measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.	3 Months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): August 19, 2021
• Study Completion (Anticipated): August 19, 2022

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: 2016-6572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will not share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No