Stroke, SubacuteNCT06582303
Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation
A study testing Virtual reality Game intervention plus conventional physical therapy and Conventional Physical Therapy in people with Stroke, Subacute, run by National University of Science and Technology, Pakistan at 1 site in Pakistan.
Trial summary
The study was a randomized control trial conducted to determine whether VR games incorporated with cognitive engagement within visual training feedback are feasible intervention options in stroke rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Subacute
- What is being tested?
- Virtual reality Game intervention plus conventional physical therapy and Conventional Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Nov 2022to 31 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment (MOCA ≥ 21)
- Modified Ashworth Scale (MAS< 4)
- Fugl-Meyer Assessment (FMA between 25 and 55)
- Age ≥ 18 years
- Stroke patient type (Subacute patients)
Who cannot join
- Wrist Impairments
- Contractures
- Patients with vestibular issues
- Permanent external fixation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Physiotherapy Department, Holy Family Hospital.
Rawalpindi, Punjab Province, 46000
About this study
The study was a randomized control trial conducted to determine whether VR games incorporated with cognitive engagement within visual training feedback are feasible intervention options in stroke rehabilitation. An investigation has been conducted to assess the efficacy of virtual reality games that enhance hand motor functions to attain long-lasting improvements. Patients were randomly assigned to the experimental and control groups. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week, for a total duration of 6 weeks. Developed four VR-based hand games that include hitting a rolling ball, grasping a balloon, swapping hands, and gripping a pencil.
Read the detailed description
The field of stroke rehabilitation frequently faces limitations in therapies and struggles to achieve long-lasting improvements in hand motor function. The integration of fully immersive virtual reality (VR) games with visual training feedback significantly improves the efficacy of stroke rehabilitation. Virtual reality (VR) games that incorporate repetitive and particular tasks stimulate the gradual activation of brain pathways linked to motor activities. VR research has the potential to enhance VR intervention games by combining cognitive engagement with visual feedback.
The objective of this study was to develop and evaluate virtual reality games that utilize an approach of cognitive engagement within visual feedback in order to enhance hand-motor capabilities. The study utilized completely immersive virtual reality (VR) games specifically designed for subacute stroke patients. The implementation of fully immersive virtual reality (VR) games as an intervention proved to be highly effective in significantly maintaining the motor recovery of patients who had experienced a stroke in the subacute phase. Stroke patients exhibited enhanced dexterity, heightened range of motion, greater hand strength, and improved grip.
Developed VR games utilize a virtual reality device and are designed to be controlled by hand movements such as flexion/extension, close/open, supination/pronation, and pinch. Patients were randomly assigned to the experimental and control groups. The experimental group received a VR hand game intervention with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks.
- Conditions
- Stroke, Subacute
- Being tested
- Virtual reality Game intervention plus conventional physical therapy, Conventional Physical Therapy
- Keywords
- VR games, Visual feedback, Intervention, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality Game intervention plus conventional physical therapyDevice
Also called VRGI+CPT
The experimental group initially got VR intervention by playing all four easy-level games named hitting a rolling ball, grasping a balloon, swapping hands, and gripping twice for three minutes each during the first and second weeks. This group again underwent VR intervention by playing all four same games with a difficulty level twice 5 min duration for the third, fourth, fifth, and sixth weeks. The experimental group had an intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. During the first two weeks, patients received 24 minutes of VR hand games and 24 minutes of therapy sessions per day and for the next four weeks, this group received 40 minutes of VR hand games and 40 minutes of conventional therapy session per day. This group received conventional physical therapy that consists of range of motion, stretching, resistance, and strengthening exercises. At follow-up of two weeks this group only received conventional physical therapy.
Conventional Physical TherapyDevice
Also called CPT
The control group received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises by using powerweb, thera putty, and occupational therapy equipment. The CPT group had a conventional intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. The CPT group was given 48 minutes of conventional physical therapy sessions per day for weeks 1 and 2 followed by 80 minutes of conventional physical therapy sessions per day for the next 4 weeks. At follow-up of two weeks, this group also received conventional physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Virtual reality intervention plus conventional physical therapy | Experimental | The experimental group initially got VR intervention by playing all four easy-level games twice for three minutes each during the first and second weeks. This group again underwent VR intervention, playing all four same games with a difficulty level of twice 5 min duration for the third, fourth, fifth, and sixth weeks. The experimental group had an intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. During the first two weeks, patients received 24 minutes of VR hand games and 24 minutes of therapy sessions per day and for the next four weeks, this group received 40 minutes of VR hand games and 40 minutes of conventional therapy session per day. This group received conventional physical therapy that consists of range of motion, stretching, resistance, and strengthening exercises. At follow-up of two weeks this group only received conventional physical therapy. Receives: Device: Virtual reality Game intervention plus conventional physical therapy |
| Control Group: Conventional physical therapy | Active comparator | The control group received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises. The CPT group had a conventional intervention of 24 sessions, lasting 4 days per week for a total of 6 weeks. The CPT group was given 48 minutes of conventional physical therapy sessions per day for weeks 1 and 2, followed by 80 minutes of conventional physical therapy sessions per day for the next 4 weeks. At a follow-up of two weeks, this group also received conventional physical therapy. Receives: Device: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
The Fugl-Meyer Assessment-Upper Extremity subscale was employed to examine the motor function restoration in the upper extremity of stroke patients following interventions. The Fugl-Meyer Assessment-Upper Extremity consists of 33 items that assess motor function, with a scoring range of 0-66, The minimum score 0 represents severe impairment, and maximum score 66 represents normal motor function. Higher scores indicate better motor function.
Measured: Baseline, 4th week, 6th week, and 9th week (follow-up)
Action Research Arm Test (ARAT)
The Action Research Arm Test is utilized to examine the functional capabilities of stroke patients upper extremities, specifically in terms of reaching, gripping, pinching, and overall movement tasks. Each item is allocated a rating score of 4 points, with the potential total values ranging from 0 to 57. The minimum score 0 represents severe impairment, and the maximum score 57 represents normal upper extremity function. Higher scores on the Action Research Arm Test indicate better functional capabilities of the upper extremities.
Measured: Baseline, 4th week, 6th week, and 9th week (follow-up)
Box and Block Test (BBT)
The BBT evaluated the manual dexterity of individuals who had suffered a stroke. During this assessment, participants are required to transfer blocks from one container to another within a one-minute time limit.
Measured: Baseline, 4th week, 6th week, and 9th week (follow-up)
Correlation between electromyography signal features and clinical outcomes
Electromyography signals are obtained in order to evaluate the electrical activity generated by muscles. Electromyography was utilized for the objective assessment of the effectiveness of immersive VR-based hand games. The objective assessment includes the evaluation of the correlation between electromyography signal features and clinical outcomes, which includes the Fugl-Meyer Assessment-Upper Extremity, Action Research Arm Test, and Box and Block Test.
Measured: Baseline, 4th week, 6th week, and 9th week (follow-up)
Movement performance
The weekly movement performance was evaluated by machine learning algorithms that include k-nearest neighbors, random forest, and support vector machine classifiers on the electromyography signals of stroke patients.
Measured: Baseline, 4th week, 6th week, and 9th week (follow-up)
Secondary outcomes (2)
Modified Barthel Index (MBI)
The Modified Barthel Index assesses an individual\'s ability to perform both practical and routine tasks independently. The Modified Barthel Index consists of 10 items, each scored based on the level of assistance required or the level of autonomy demonstrated by the patient. The total score ranges from a minimum of 0 to a maximum of 20. Lower scores indicate greater dependence, with scores below 10 typically representing severe disability and scores below 15 usually indicating moderate disability. Moreover, higher scores reflect greater independence in performing daily activities.
Measured: Baseline and 9th week (follow-up)
Stroke-Specific Quality of Life (SSQOL)
The Stroke-Specific Quality of Life measure was used to assess the health-related quality of life of stroke survivors. The Stroke-Specific Quality of Life scale consists of 49 comprehensive items that evaluate various aspects of quality of life based on the patient's current state. The total score ranges from a minimum of 49 to a maximum of 245. Lower scores indicate poorer health-related quality of life, and higher scores indicate better health-related quality of life.
Measured: Baseline and 9th week (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start14 Nov 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke, SubacuteStudies 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
- Model description
- Subacute stroke patients were randomly assigned to the experimental group and the control group. The experimental group received a VR hand game intervention along with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks. The VR intervention consists of four games that utilize a virtual reality device and are controlled by affected hand movements such as flexion/extension, close/open, supination/pronation, and pinch. The control group and experimental groups received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Science and Technology, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Asim Waris, National University of Science and Technology, Pakistan
- Investigators
- Asim Waris, PhD, Study chair, National University of Sciences and Technology (NUST), Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582303
- Sponsor's protocol ID
- BMES/REC/22/027
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bae S, Park HS. Development of Immersive Virtual Reality-Based Hand Rehabilitation System Using a Gesture-Controlled Rhythm Game With Vibrotactile Feedback: An fNIRS Pilot Study. IEEE Trans Neural Syst Rehabil Eng. 2023;31:3732-3743. doi: 10.1109/TNSRE.2023.3312336. Epub 2023 Sep 28.
PubMed 37669214Fregna G, Schincaglia N, Baroni A, Straudi S, Casile A. A novel immersive virtual reality environment for the motor rehabilitation of stroke patients: A feasibility study. Front Robot AI. 2022 Aug 29;9:906424. doi: 10.3389/frobt.2022.906424. eCollection 2022.
PubMed 36105763Lange B, Koenig S, Chang CY, McConnell E, Suma E, Bolas M, Rizzo A. Designing informed game-based rehabilitation tasks leveraging advances in virtual reality. Disabil Rehabil. 2012;34(22):1863-70. doi: 10.3109/09638288.2012.670029. Epub 2012 Apr 12.
PubMed 22494437Hernandez A, Bubyr L, Archambault PS, Higgins J, Levin MF, Kairy D. Virtual Reality-Based Rehabilitation as a Feasible and Engaging Tool for the Management of Chronic Poststroke Upper-Extremity Function Recovery: Randomized Controlled Trial. JMIR Serious Games. 2022 Sep 27;10(3):e37506. doi: 10.2196/37506.
PubMed 36166289Huang J, Lin M, Fu J, Sun Y, Fang Q. An Immersive Motor Imagery Training System for Post-Stroke Rehabilitation Combining VR and EMG-based Real-Time Feedback. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:7590-7593. doi: 10.1109/EMBC46164.2021.9629767.
PubMed 34892847Amin F, Waris A, Syed S, Amjad I, Umar M, Iqbal J, Omer Gilani S. Effectiveness of Immersive Virtual Reality-Based Hand Rehabilitation Games for Improving Hand Motor Functions in Subacute Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2024;32:2060-2069. doi: 10.1109/TNSRE.2024.3405852. Epub 2024 May 30.
PubMed 38801680
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT06582303
- Acronym / sponsor ID
- BMES/REC/22/027
- Conditions
- Stroke, Subacute
- Keywords
- VR games, Visual feedback, Intervention, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National University of Science and Technology, PakistanUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 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 study was a randomized control trial conducted to determine whether VR games incorporated with cognitive engagement within visual training feedback are feasible intervention options in stroke rehabilitation. An investigation has been conducted to assess the efficacy of virtual reality games that enhance hand motor functions to attain long-lasting improvements. Patients were randomly assigned to the experimental and control groups. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week, for a total duration of 6 weeks. Developed four VR-based hand games that include hitting a rolling ball, grasping a balloon, swapping hands, and gripping a pencil.
Detailed description
The field of stroke rehabilitation frequently faces limitations in therapies and struggles to achieve long-lasting improvements in hand motor function. The integration of fully immersive virtual reality (VR) games with visual training feedback significantly improves the efficacy of stroke rehabilitation. Virtual reality (VR) games that incorporate repetitive and particular tasks stimulate the gradual activation of brain pathways linked to motor activities. VR research has the potential to enhance VR intervention games by combining cognitive engagement with visual feedback.
The objective of this study was to develop and evaluate virtual reality games that utilize an approach of cognitive engagement within visual feedback in order to enhance hand-motor capabilities. The study utilized completely immersive virtual reality (VR) games specifically designed for subacute stroke patients. The implementation of fully immersive virtual reality (VR) games as an intervention proved to be highly effective in significantly maintaining the motor recovery of patients who had experienced a stroke in the subacute phase. Stroke patients exhibited enhanced dexterity, heightened range of motion, greater hand strength, and improved grip.
Developed VR games utilize a virtual reality device and are designed to be controlled by hand movements such as flexion/extension, close/open, supination/pronation, and pinch. Patients were randomly assigned to the experimental and control groups. The experimental group received a VR hand game intervention with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subacute stroke patients were randomly assigned to the experimental group and the control group. The experimental group received a VR hand game intervention along with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks. The VR intervention consists of four games that utilize a virtual reality device and are controlled by affected hand movements such as flexion/extension, close/open, supination/pronation, and pinch. The control group and experimental groups received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Virtual reality intervention plus conventional physical therapy | Experimental | Device: Virtual reality Game intervention plus conventional physical therapyThe experimental group initially got VR intervention by playing all four easy-level games twice for three minutes each during the first and second weeks. This group again underwent VR intervention, playing all four same games with a difficulty level of twice 5 min duration for the third, fourth, fifth, and sixth weeks. The experimental group had an intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. During the first two weeks, patients received 24 minutes of VR hand games and 24 minutes of therapy sessions per day and for the next four weeks, this group received 40 minutes of VR hand games and 40 minutes of conventional therapy session per day. This group received conventional physical therapy that consists of range of motion, stretching, resistance, and strengthening exercises. At follow-up of two weeks this group only received conventional physical therapy. |
| Control Group: Conventional physical therapy | Active comparator | Device: Conventional Physical TherapyThe control group received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises. The CPT group had a conventional intervention of 24 sessions, lasting 4 days per week for a total of 6 weeks. The CPT group was given 48 minutes of conventional physical therapy sessions per day for weeks 1 and 2, followed by 80 minutes of conventional physical therapy sessions per day for the next 4 weeks. At a follow-up of two weeks, this group also received conventional physical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Montreal Cognitive Assessment (MOCA ≥ 21)
- Modified Ashworth Scale (MAS< 4)
- Fugl-Meyer Assessment (FMA between 25 and 55)
- Age ≥ 18 years
- Stroke patient type (Subacute patients)
Key exclusion criteria (4 listed)
- Wrist Impairments
- Contractures
- Patients with vestibular issues
- Permanent external fixation
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 |
|---|---|---|
| Virtual reality Game intervention plus conventional physical therapyAlso: VRGI+CPTThe experimental group initially got VR intervention by playing all four easy-level games named hitting a rolling ball, grasping a balloon, swapping hands, and gripping twice for three minutes each during the first and second weeks. This group again underwent VR intervention by playing all four same games with a difficulty level twice 5 min duration for the third, fourth, fifth, and sixth weeks. The experimental group had an intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. During the first two weeks, patients received 24 minutes of VR hand games and 24 minutes of therapy sessions per day and for the next four weeks, this group received 40 minutes of VR hand games and 40 minutes of conventional therapy session per day. This group received conventional physical therapy that consists of range of motion, stretching, resistance, and strengthening exercises. At follow-up of two weeks this group only received conventional physical therapy. | Device | Experimental Group: Virtual reality intervention plus conventional physical therapy |
| Conventional Physical TherapyAlso: CPTThe control group received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises by using powerweb, thera putty, and occupational therapy equipment. The CPT group had a conventional intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. The CPT group was given 48 minutes of conventional physical therapy sessions per day for weeks 1 and 2 followed by 80 minutes of conventional physical therapy sessions per day for the next 4 weeks. At follow-up of two weeks, this group also received conventional physical therapy. | Device | Control Group: Conventional physical therapy |
Primary outcome
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
The Fugl-Meyer Assessment-Upper Extremity subscale was employed to examine the motor function restoration in the upper extremity of stroke patients following interventions. The Fugl-Meyer Assessment-Upper Extremity consists of 33 items that assess motor function, with a scoring range of 0-66, The minimum score 0 represents severe impairment, and maximum score 66 represents normal motor function. Higher scores indicate better motor function.
Action Research Arm Test (ARAT)
Time frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
The Action Research Arm Test is utilized to examine the functional capabilities of stroke patients upper extremities, specifically in terms of reaching, gripping, pinching, and overall movement tasks. Each item is allocated a rating score of 4 points, with the potential total values ranging from 0 to 57. The minimum score 0 represents severe impairment, and the maximum score 57 represents normal upper extremity function. Higher scores on the Action Research Arm Test indicate better functional capabilities of the upper extremities.
Box and Block Test (BBT)
Time frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
The BBT evaluated the manual dexterity of individuals who had suffered a stroke. During this assessment, participants are required to transfer blocks from one container to another within a one-minute time limit.
Correlation between electromyography signal features and clinical outcomes
Time frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
Electromyography signals are obtained in order to evaluate the electrical activity generated by muscles. Electromyography was utilized for the objective assessment of the effectiveness of immersive VR-based hand games. The objective assessment includes the evaluation of the correlation between electromyography signal features and clinical outcomes, which includes the Fugl-Meyer Assessment-Upper Extremity, Action Research Arm Test, and Box and Block Test.
Movement performance
Time frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
The weekly movement performance was evaluated by machine learning algorithms that include k-nearest neighbors, random forest, and support vector machine classifiers on the electromyography signals of stroke patients.
2 secondary outcomes
Modified Barthel Index (MBI)
Time frame: Baseline and 9th week (follow-up)
Stroke-Specific Quality of Life (SSQOL)
Time frame: Baseline and 9th week (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 37669214Bae S, Park HS. Development of Immersive Virtual Reality-Based Hand Rehabilitation System Using a Gesture-Controlled Rhythm Game With Vibrotactile Feedback: An fNIRS Pilot Study. IEEE Trans Neural Syst Rehabil Eng. 2023;31:3732-3743. doi: 10.1109/TNSRE.2023.3312336. Epub 2023 Sep 28.
- Background: PubMed 36105763Fregna G, Schincaglia N, Baroni A, Straudi S, Casile A. A novel immersive virtual reality environment for the motor rehabilitation of stroke patients: A feasibility study. Front Robot AI. 2022 Aug 29;9:906424. doi: 10.3389/frobt.2022.906424. eCollection 2022.
- Background: PubMed 22494437Lange B, Koenig S, Chang CY, McConnell E, Suma E, Bolas M, Rizzo A. Designing informed game-based rehabilitation tasks leveraging advances in virtual reality. Disabil Rehabil. 2012;34(22):1863-70. doi: 10.3109/09638288.2012.670029. Epub 2012 Apr 12.
- Background: PubMed 36166289Hernandez A, Bubyr L, Archambault PS, Higgins J, Levin MF, Kairy D. Virtual Reality-Based Rehabilitation as a Feasible and Engaging Tool for the Management of Chronic Poststroke Upper-Extremity Function Recovery: Randomized Controlled Trial. JMIR Serious Games. 2022 Sep 27;10(3):e37506. doi: 10.2196/37506.
- Background: PubMed 34892847Huang J, Lin M, Fu J, Sun Y, Fang Q. An Immersive Motor Imagery Training System for Post-Stroke Rehabilitation Combining VR and EMG-based Real-Time Feedback. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:7590-7593. doi: 10.1109/EMBC46164.2021.9629767.
- Results publication: PubMed 38801680Amin F, Waris A, Syed S, Amjad I, Umar M, Iqbal J, Omer Gilani S. Effectiveness of Immersive Virtual Reality-Based Hand Rehabilitation Games for Improving Hand Motor Functions in Subacute Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2024;32:2060-2069. doi: 10.1109/TNSRE.2024.3405852. Epub 2024 May 30.
- Individual participant dataSharing planned: No
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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.
Asim Waris, PhD study chair
National University of Sciences and Technology (NUST), Islamabad, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality Game intervention plus conventional physical therapy and Conventional Physical Therapy in people with Stroke, Subacute, run by National University of Science and Technology, Pakistan at 1 site in Pakistan.
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 4 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: finished, as of the sponsor's last update on 3 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment-Upper Extremity (FMA-UE) (time frame: Baseline, 4th week, 6th week, and 9th week (follow-up)). The study lists 5 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 NCT06582303, which also lists 6 linked publications.
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 3 Sep 2024.