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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Therapy + Immersive Virtual Reality Therapy | Experimental | 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. |
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| Conventional Therapy + Non Immersive Virtual Reality Therapy | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment for upper extremity (FMA-UE) | 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. | From enrollment to the end treatment at 6 weeks |
| Graded Wolf Motor function test - The WMFT | 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. | From enrollment to the end treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Specific Quality of Life Scale (SS-QOL) | 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. | From enrollment to the end treatment at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Athira George, MPT | Contact | +971503723635 | 2022mpt09@mygmu.ac.ae | |
| Dr.Satheeskumar Durairaj | Contact | +971 55 1808474 | satheeskumar@gmu.ac.ae |
| Name | Affiliation | Role |
|---|---|---|
| Athira George, Master of Physical Therapy | Gulf Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thumbay Physical Therapy and Rehabilitation Hospital | Recruiting | Ajman | 00000 | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41455908 | Derived | George A, Durairaj SK, Kandakurti PK, Hazari A. Immersive versus non-immersive virtual reality in improving upper limb function among individuals with subacute hemiplegia: a randomized controlled trial. BMC Neurol. 2025 Dec 28;26(1):60. doi: 10.1186/s12883-025-04588-5. |
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Confidentiality of patient data must be maintained as per consent form.
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| 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. |
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