Virtual Reality in Stroke Rehabilitation

NCT04080791 | Withdrawn FDA Device

• 1 other identifier: IRB00052687
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to investigate the effects of Virtual Reality (VR) as a treatment intervention to increase physical and cognitive function in stroke survivors.

Conditions

Ischemic Stroke

Keywords

Virtual Reality; Stroke; National Stroke Association; Stroke Rehabilitation

Outcome Measures

Primary Outcomes (6)

• Montreal Cognitive Assessment (MoCA)

  Scores range from 0 to 30 with higher scores denoting better outcomes.

  baseline

• Montreal Cognitive Assessment (MoCA)

  Scores range from 0 to 30 with higher scores denoting better outcomes.

  Up to 8 days after baseline

• Modified Functional Reach Test (MFRT)

  The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls.

  baseline

• Modified Functional Reach Test (MFRT)

  The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls.

  Up to 8 days after baseline

• FMA-UE (Fugl-Meyer Assessment for Upper Extremity)

  Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome.

  baseline

• FMA-UE (Fugl-Meyer Assessment for Upper Extremity)

  Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome.

  Up to 8 days after baseline

Secondary Outcomes (4)

• Pain intensity self-report ratings

  prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline

• Pain intensity self-report ratings

  immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline

• Wong-Baker FACES scale

  prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline

• Wong-Baker FACES scale

  immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline

Study Arms (2)

Experimental Group- Virtual Reality (VR) Treatment

EXPERIMENTAL

The participants in the experimental group will complete the educational/training session on how to use the VR equipment and programs (30 minutes). The following day, participants will begin the VR intervention attending a daily 30-minute sessions for 8 days or until a discharge date has been set, whichever comes first.

Device: Virtual Reality (VR) System; Procedure: Standard of care

Standard of care group

ACTIVE COMPARATOR

The control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol. Prior to discharge, control group participants will meet with a licensed clinical therapist to complete the cognitive and physical assessments for the posttest evaluation.

Procedure: Standard of care

Interventions

Virtual Reality (VR) System DEVICE

The participants will undergo daily 30-minute sessions for 8 days of Virtual Reality (VR) with a VR system using commercially available default programs in addition to traditional intensive therapy regimen provided during inpatient rehab.

Experimental Group- Virtual Reality (VR) Treatment

Standard of care PROCEDURE

Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.

Experimental Group- Virtual Reality (VR) Treatment; Standard of care group

Eligibility Criteria

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

You may qualify if:

• Patients Age 18 and older admitted to inpatient rehabilitation with a projected LOS (length of stay) of 10 days or more within the open data collection period for treatment of ischemic stroke and agree to participate in the study in addition to traditional intensive rehabilitation therapy.

You may not qualify if:

• Individual patients who exhibit the following symptoms or medical history or are not medically cleared for participation will be excluded:
• History of, or high risk for, seizures
• Feed tube, tracheotomy, or other medical devices that would preclude the use or wear of the VR headset as it covers the face and head
• Blindness
• History of mental health issues such as schizophrenia, manic episodes, active psychosis, or other mental health issues that may be exacerbated by exposure to VR
• Open wounds that would preclude use for the VR headset

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Related Publications (4)

• Henderson A, Korner-Bitensky N, Levin M. Virtual reality in stroke rehabilitation: a systematic review of its effectiveness for upper limb motor recovery. Top Stroke Rehabil. 2007 Mar-Apr;14(2):52-61. doi: 10.1310/tsr1402-52.

  PMID: 17517575 BACKGROUND

• National Stroke Association, (2018) Stroke 101: Fast facts on stroke, accessed from url http://www.stroke.org/sites/default/files/resources/NSA_%20FactSheet_Strok e_101_2014.pdf

  BACKGROUND

• Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.

  PMID: 23914733 BACKGROUND

• IBM Corp. (2012). IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp

  BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Drug Delivery Systems; Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Peggy Cromer, LRT

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: March 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share