Hemiplegia and/or Hemiparesis Following Stroke
Conditions
Keywords
virtual reality, hemiplegic stroke, Oculus Quest 3, Motor function, Upper limb
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.
Interventions
DEVICEOculus 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.
DEVICENeofect 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.
Sponsors
Gulf Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment for upper extremity (FMA-UE) | 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. |
| Graded Wolf Motor function test - The WMFT | 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
| Measure | Time frame | Description |
|---|---|---|
| Stroke Specific Quality of Life Scale (SS-QOL) | 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. |
Countries
United Arab Emirates
Contacts
Primary ContactAthira George, MPT
Backup ContactDr.Satheeskumar Durairaj
Outcome results
None listed