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

Not Applicable
Recruiting
Conditions
Hemiplegia and/or Hemiparesis Following Stroke
Interventions
Device: Oculus Quest 3
Device: Neofect Smartboard and Tyromotion Myro
Registration Number
NCT06615141
Lead Sponsor
Gulf Medical University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conventional Therapy + Immersive Virtual Reality TherapyOculus Quest 315 minutes of conventional therapy followed by 45 minutes of immersive virtual reality therapy will be administered to this group referred to as Group 1.
Conventional Therapy + Non Immersive Virtual Reality TherapyNeofect Smartboard and Tyromotion Myro15 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
Primary Outcome Measures
NameTimeMethod
Fugl-Meyer Assessment for upper extremity (FMA-UE)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 WMFTFrom 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 Outcome Measures
NameTimeMethod
Stroke Specific Quality of Life Scale (SS-QOL)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.

Trial Locations

Locations (1)

Thumbay Physical Therapy and Rehabilitation Hospital

🇦🇪

Ajman, United Arab Emirates

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