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Clinical Trials/NCT04080791
NCT04080791
Withdrawn
N/A

Efficacy of Virtual Reality in Stroke Rehabilitation

ConditionsIschemic Stroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Wake Forest University Health Sciences
Primary Endpoint
Montreal Cognitive Assessment (MoCA)
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Detailed Description

In this pilot study, the objective is to determine if there is an increase in MoCA (Montreal Cognitive Assessment), MFRT (Modified Functional Reach Test), and FMA-UA (Fugl-Meyer Assessment Upper Extremity) scores of participants who receive the VR intervention in addition to traditional inpatient rehabilitation standard of care (experimental group) versus participants who receive the traditional standard of care (control group).

Registry
clinicaltrials.gov
Start Date
March 2023
End Date
January 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Montreal Cognitive Assessment (MoCA)

Time Frame: Up to 8 days after baseline

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

Modified Functional Reach Test (MFRT)

Time Frame: Up to 8 days after baseline

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.

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

Time Frame: Up to 8 days after baseline

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.

Secondary Outcomes

  • Wong-Baker FACES scale(immediately after 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)

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