Hemiplegia and/or Hemiparesis Following StrokeNCT06615141
Immersive v/s Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia
A study testing Oculus Quest 3 and Neofect Smartboard and Tyromotion Myro in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 55 years
- Conditions the study is for
- Hemiplegia and/or Hemiparesis Following Stroke
- What is being tested?
- Oculus Quest 3 and Neofect Smartboard and Tyromotion Myro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 5 Mar 2024to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Thumbay Physical Therapy and Rehabilitation Hospital
Ajman, 00000
Athira George, MPT, +971503723635, 2022mpt09@mygmu.ac.ae
About this study
Official title: Immersive Versus Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia - A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Oculus Quest 3, Neofect Smartboard and Tyromotion Myro
- Keywords
- virtual reality, hemiplegic stroke, Oculus Quest 3, Motor function, Upper limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Quest 3Device
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.
Neofect Smartboard and Tyromotion MyroDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oculus Quest 3 |
| 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 Receives: Device: Neofect Smartboard and Tyromotion Myro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end treatment at 6 weeks
Secondary outcomes (1)
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.
Measured: From enrollment to the end treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start5 Mar 2024
- Primary completion5 Jan 2025 (estimated)
- Study completion5 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiplegia and/or Hemiparesis Following StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athira George, Gulf Medical University
- Investigators
- Athira George, Master of Physical Therapy, Principal investigator, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615141
- Sponsor's protocol ID
- IRB-COHS-STD-75-FEB-2024
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality of patient data must be maintained as per consent form.
Publications
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.
PubMed 41455908
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Versus Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06615141
- Acronym / sponsor ID
- IRB-COHS-STD-75-FEB-2024
- Keywords
- virtual reality, hemiplegic stroke, Oculus Quest 3, Motor function, Upper limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 5 Jan 2025 (estimated)
- Study completion
- 5 Jan 2025 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy + Immersive Virtual Reality Therapy | Experimental | Device: Oculus Quest 315 minutes of conventional therapy followed by 45 minutes of immersive virtual reality therapy will be administered to this group referred to as Group 1. |
| Conventional Therapy + Non Immersive Virtual Reality Therapy | Experimental | Device: Neofect Smartboard and Tyromotion Myro15 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 |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculus Quest 3Oculus 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. | Device | Conventional Therapy + Immersive Virtual Reality Therapy |
| Neofect Smartboard and Tyromotion MyroNeofect 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. | Device | Conventional Therapy + Non Immersive Virtual Reality Therapy |
Primary outcome
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Time frame: 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
Time frame: 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.
1 secondary outcome
Stroke Specific Quality of Life Scale (SS-QOL)
Time frame: From enrollment to the end treatment at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 41455908George 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.
- Individual participant dataSharing planned: No. Confidentiality of patient data must be maintained as per consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athira George, Master of Physical Therapy principal investigator
Gulf Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Quest 3 and Neofect Smartboard and Tyromotion Myro in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Gulf Medical University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athira George, MPT (+971503723635, 2022mpt09@mygmu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for upper extremity (FMA-UE) (time frame: From enrollment to the end treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06615141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.