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

NCT06615141 | Recruiting

• 1 other identifier: IRB-COHS-STD-75-FEB-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia and/or Hemiparesis Following Stroke

Keywords

virtual reality; hemiplegic stroke; Oculus Quest 3; Motor function; Upper limb

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment for upper extremity (FMA-UE)

  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

  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 Outcomes (1)

• Stroke Specific Quality of Life Scale (SS-QOL)

  From enrollment to the end treatment at 6 weeks

Study Arms (2)

Conventional Therapy + Immersive Virtual Reality Therapy

EXPERIMENTAL

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

Conventional Therapy + Non Immersive Virtual Reality Therapy

EXPERIMENTAL

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

Interventions

Oculus Quest 3 DEVICE

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.

Conventional Therapy + Immersive Virtual Reality Therapy

Neofect Smartboard and Tyromotion Myro DEVICE

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.

Conventional Therapy + Non Immersive Virtual Reality Therapy

Eligibility Criteria

• Age: 28 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Thumbay Physical Therapy and Rehabilitation Hospital

Ajman, 00000, United Arab Emirates

RECRUITING

Related Publications (1)

• 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. doi: 10.1186/s12883-025-04588-5. Online ahead of print.

  PMID: 41455908 DERIVED

Study Officials

• Athira George, Master of Physical Therapy

  Gulf Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Athira George, MPT

CONTACT

+971503723635; 2022mpt09@mygmu.ac.ae

Dr.Satheeskumar Durairaj

CONTACT

+971 55 1808474; satheeskumar@gmu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 26, 2024
• Study Start: March 5, 2024
• Primary Completion: January 5, 2025
• Study Completion: January 5, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)