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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03039764
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Gary Inwald, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE February 1, 2017
Last Update Posted Date October 1, 2020
Actual Study Start Date  ICMJE April 30, 2018
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Virtual Reality Based Rehabilitation in Acute Stroke Patients in an Inpatient Rehab Setting
Official Title  ICMJE The Comparison Study of Virtual Reality Rehabilitation With Standard Occupational Therapy Versus Standard Occupational Therapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke Syndrome
  • Hemiplegia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Rapael
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gary Inwald, MD 718-920-9393 ginwald@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03039764
Other Study ID Numbers  ICMJE 2016-6572
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Will not share IPD
Responsible Party Gary Inwald, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Montefiore Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP