Immersive v/s Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia

September 25, 2024 updated by: Athira George, Gulf Medical University

Immersive Versus Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia - A Randomized Controlled Trial

The goal of this randomized controlled trial is to compare the effectiveness of immersive virtual reality combined with conventional therapy to the effectiveness of non-immersive virtual reality combined with conventional therapy in enhancing upper limb function in subacute hemiplegic stroke patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a single blinded randomized controlled trial in which the assessor will be blinded. Male and female participants aged between 28-55 years are included in the study. Participants are selected based on inclusion and exclusion criteria and are later randomly assigned to Group 1 and Group 2.

Group 1 - Conventional therapy and Immersive Virtual Reality Group 2 - Conventional therapy and Non-Immersive Virtual Reality

Primary Outcome measures include the Fugl Meyer Assessment for Upper limb and Graded Wolf Motor Function test for upper limb.

Secondary Outcome measure is the Stroke Specific Quality of Life Scale (SS-QOL) Questionnaire.

Therapy session starts with 15 minutes of stretching and strengthening exercises of the affected arm followed by 45 minutes of Immersive / Non Immersive virtual reality training.

Follow up assessment is done 6 weeks post intervention.

The baseline assessment score and follow up assessment scores will be compared.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Arab Emirates
      • Ajman, United Arab Emirates, 00000
        • Recruiting
        • Thumbay Physical Therapy and Rehabilitation Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals aged 28-55 years.
  • Diagnosed with hemiplegia due to stroke.
  • ≤ Grade 2 on Modified Ashworth scale.
  • ≤ Stage 2 on Brunnstrom stages of motor recovery.
  • Score of ≥ 35/36 on Cognitive assessment scale for stroke patients (CASP)

Exclusion Criteria:

  • Contraindications for VR therapy, such as severe motion sickness or photosensitive epilepsy, impaired spatial awareness.
  • Pre-existing neurological conditions such as spinal cord injury, Multiple sclerosis and so affecting upper limb function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Therapy + Immersive Virtual Reality Therapy
15 minutes of conventional therapy followed by 45 minutes of immersive virtual reality therapy will be administered to this group referred to as Group 1.
Device: Oculus Quest 3
Oculus quest 3 is a standalone virtual reality headset developed by Meta. It offers precise motion tracking and offers an innovative intervention for stroke rehabilitation, enhancing upper limb motor function throug task - specific exercises.
Experimental: Conventional Therapy + Non Immersive Virtual Reality Therapy
15 minutes of conventional therapy followed by 45 minutes of non-immersive virtual reality therapy will be administered to this group referred to as Group 2
Device: Neofect Smartboard and Tyromotion Myro

Neofect Smart Board provides non-immersive VR rehabilitation through gamified, task specific exercises to improve upper limb mobility in an interactive way.

Tyromotion Myro uses non-immersive VR therapy combining sensor-based feedback and interactive games to enhance fine motor skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Time Frame: From enrollment to the end treatment at 6 weeks
A valid, reliable, and comprehensive measurement tool with an intra-rater reliability of ICC 0.96 and interrater reliability of ICC 0.98, used to evaluate motor impairment, balance, sensation, and joint function in the upper extremities after stroke.
From enrollment to the end treatment at 6 weeks
Graded Wolf Motor function test - The WMFT
Time Frame: From enrollment to the end treatment at 6 weeks
This test is designed to assess motor function, strength, and coordination in individuals with upper extremity impairments. It is a reliable measure with inter-rater reliability of 0.97 and intra-rater reliability of 0.90.
From enrollment to the end treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Specific Quality of Life Scale (SS-QOL)
Time Frame: From enrollment to the end treatment at 6 weeks
The SS-QOL scale is widely used for assessing the health-related quality of life in stroke survivors. It has a good test-retest reliability, with ICC ranging from 0.80-0.90. It is a valid and reliable tool for assessing the quality of life in stroke patients.
From enrollment to the end treatment at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulf Medical University

Investigators

  • Principal Investigator: Athira George, Master of Physical Therapy, Gulf Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

January 5, 2025

Study Completion (Estimated)

January 5, 2025

Study Registration Dates

First Submitted

September 15, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-COHS-STD-75-FEB-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidentiality of patient data must be maintained as per consent form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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