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

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ClinicalTrials.gov Identifier: NCT03039764
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Gary Inwald, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Stroke Syndrome Hemiplegia Device: Rapael Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison Study of Virtual Reality Rehabilitation With Standard Occupational Therapy Versus Standard Occupational Therapy
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test [ Time Frame: 3 Months ]
    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 :
  1. Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire [ Time Frame: 3 Months ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039764


Contacts
Contact: Gary Inwald, MD 718-920-9393 ginwald@montefiore.org

Locations
United States, New York
Burke rehabilitation Hospital Recruiting
White Plains, New York, United States, 10605
Contact: Dohle Carolin, MD       cardohle@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center

Responsible Party: Gary Inwald, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03039764     History of Changes
Other Study ID Numbers: 2016-6572
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not share IPD

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms