Immersive Versus Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia - A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hemiplegia and/or Hemiparesis Following Stroke
- Sponsor
- Gulf Medical University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment for upper extremity (FMA-UE)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
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.
Investigators
Athira George
Principal Investigator
Gulf Medical University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Stroke Specific Quality of Life Scale (SS-QOL)(From enrollment to the end treatment at 6 weeks)