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

Primary Purpose

Stroke Syndrome, Hemiplegia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rapael
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Burke rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard occupational therapy

SOT plus VR Rapael

Arm Description

This group will receiving standard occupational therapy for the treatment of acute stroke.

This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 17, 2017
Last Updated
May 4, 2022
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03039764
Brief Title
Effects of Virtual Reality Based Rehabilitation in Acute Stroke Patients in an Inpatient Rehab Setting
Official Title
The Comparison Study of Virtual Reality Rehabilitation With Standard Occupational Therapy Versus Standard Occupational Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Paused due to COVID and the study has expired. The PI left the institution in 2021 and another PI has not been assigned.
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
August 19, 2021 (Actual)
Study Completion Date
August 19, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Syndrome, Hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard occupational therapy
Arm Type
No Intervention
Arm Description
This group will receiving standard occupational therapy for the treatment of acute stroke.
Arm Title
SOT plus VR Rapael
Arm Type
Experimental
Arm Description
This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.
Intervention Type
Device
Intervention Name(s)
Rapael
Intervention Description
This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.
Primary Outcome Measure Information:
Title
Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire
Description
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.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Burke rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will not share IPD

Learn more about this trial

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

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