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

Gulf Medical University

Status: Enrolling

Conditions: Hemiplegia and/or Hemiparesis Following Stroke

Treatments: Device: Oculus Quest 3; Device: Neofect Smartboard and Tyromotion Myro

Study type: Interventional

Funder types: Other

Identifiers

NCT06615141

IRB-COHS-STD-75-FEB-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 28 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Conventional Therapy + Immersive Virtual Reality Therapy

Experimental group

Description:

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.

Treatment:

Device: Oculus Quest 3

Conventional Therapy + Non Immersive Virtual Reality Therapy

Experimental group

Description:

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

Treatment:

Device: Neofect Smartboard and Tyromotion Myro