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Recruiting NCT06615141

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

No phase Interventional Hemiplegia and/or Hemiparesis Following Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oculus Quest 3, Neofect Smartboard and Tyromotion Myro.
Who it may be relevant to
Registry conditions: Hemiplegia and/or Hemiparesis Following Stroke. Basic parameters: 28 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Fugl-Meyer Assessment for upper extremity (FMA-UE) [Time frame: 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]
Secondary outcome measures (1)
  • Stroke Specific Quality of Life Scale (SS-QOL) [Time frame: From enrollment to the end treatment at 6 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United Arab Emirates · 1 center
  • Thumbay Physical Therapy and Rehabilitation Hospital — Ajman

Publications

  • George A, Durairaj SK, Kandakurti PK, Hazari A. Immersive versus non-immersive virtual reality in improving upper limb function among individuals with subacute hemiplegia: a randomized controlled trial. BMC Neurol. 2025 Dec 28;26(1):60. doi: 10.1186/s12883-025-04588-5. PMID 41455908

Identifiers

NCT: NCT06615141 · IRB-COHS-STD-75-FEB-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗