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

NCT ID: NCT06615141

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-01-05

Brief Summary

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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

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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.

Conditions

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Hemiplegia and/or Hemiparesis Following Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional Therapy + Immersive Virtual Reality Therapy

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.

Group Type EXPERIMENTAL

Oculus Quest 3

Intervention Type 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 + Non Immersive Virtual Reality Therapy

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

Group Type EXPERIMENTAL

Neofect Smartboard and Tyromotion Myro

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

28 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulf Medical University

OTHER

Sponsor Role lead

Responsible Party

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Athira George

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athira George, Master of Physical Therapy

Role: PRINCIPAL_INVESTIGATOR

Gulf Medical University

Locations

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Thumbay Physical Therapy and Rehabilitation Hospital

Ajman, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Athira George, MPT

Role: CONTACT

+971503723635

Dr.Satheeskumar Durairaj

Role: CONTACT

+971 55 1808474

Facility Contacts

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Athira George, MPT

Role: primary

+971503723635

Other Identifiers

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IRB-COHS-STD-75-FEB-2024

Identifier Type: -

Identifier Source: org_study_id

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