Clinical trial NCT06615141: Immersive v/s Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia
Official title: Immersive Versus Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia and/or Hemiparesis Following Stroke
Keywords: virtual reality
hemiplegic stroke
Oculus Quest 3
Motor function
Upper limb
Lead sponsor: Gulf Medical University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 28
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Fugl-Meyer Assessment for upper extremity (FMA-UE)
timeFrame: From enrollment to the end treatment at 6 weeks
measure: Graded Wolf Motor function test - The WMFT
timeFrame: From enrollment to the end treatment at 6 weeks
Secondary outcomes:
measure: Stroke Specific Quality of Life Scale (SS-QOL)
timeFrame: From enrollment to the end treatment at 6 weeks
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Thumbay Physical Therapy and Rehabilitation Hospital
Study officials:
affiliation: Gulf Medical University
name: Athira George, Master of Physical Therapy
role: PRINCIPAL_INVESTIGATOR
References: