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NCT Number: NCT06615141

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

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.

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Key information

Age range

28 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thumbay Physical Therapy and Rehabilitation Hospital

Ajman, 00000, United Arab Emirates

Location status: Recruiting

Location contact

Athira George, MPT

CONTACT

[email protected]

+971503723635

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Athira George, MPT

CONTACT

[email protected]

+971503723635

Dr.Satheeskumar Durairaj

CONTACT

[email protected]

+971 55 1808474

Sponsors and collaborators

Lead sponsor

Gulf Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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