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

NCT03039764 | Withdrawn FDA Device

• 1 other identifier: 2016-6572
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Syndrome; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire

  3 Months

Study Arms (2)

Standard occupational therapy

NO INTERVENTION

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

SOT plus VR Rapael

EXPERIMENTAL

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

Interventions

Rapael DEVICE

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

SOT plus VR Rapael

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Burke rehabilitation Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: February 1, 2017
• Study Start: April 30, 2018
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)