StrokeNCT06739902
Comparing the Effectiveness of Traditional Physiotherapy Combined With Virtual Reality for Post-Stroke Patients
A study testing Traditional Physiotherapy Group and VR + Traditional Physiotherapy Group in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
This study aims to evaluate the effectiveness of combining virtual reality (VR) therapy with traditional physiotherapy in post-stroke rehabilitation. Post-stroke patients often suffer from impairments in motor function, balance, and overall quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Traditional Physiotherapy Group and VR + Traditional Physiotherapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke, either ischemic or hemorrhagic
- Participants who can ambulate independently or with minimal assistance.
- Participants who were willing \& able to adhere to the study protocol.
- Including participants who were attending follow-up appointments \& completing outcome measures.
- Participants who were able to understand \& provide written informed consent
Who cannot join
- Existence of additional neurological disorders (such as multiple sclerosis or Parkinson's disease) or serious medical conditions that could prevent participants from participating in the study.
- Participants receiving rehabilitation or rigorous physical treatment in the previous three months were excluded.
- Pregnant women or breastfeeding women.
- Participants who refused to participate in the study or provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effectiveness of combining virtual reality (VR) therapy with traditional physiotherapy in post-stroke rehabilitation. Post-stroke patients often suffer from impairments in motor function, balance, and overall quality of life. While traditional physiotherapy is a widely accepted method for stroke recovery, incorporating VR technology may enhance treatment outcomes by providing an engaging, immersive environment that motivates patients to perform therapeutic movements.
Read the detailed description
This study will compare the functional and quality-of-life improvements in patients undergoing traditional physiotherapy alone versus those receiving a combination of conventional physiotherapy and VR interventions. By assessing changes in motor function, trunk stability, balance, and quality of life, this research will provide valuable insights into whether VR can be an effective adjunctive tool in post-stroke rehabilitation programs.
- Conditions
- Stroke
- Being tested
- Traditional Physiotherapy Group, VR + Traditional Physiotherapy Group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physiotherapy GroupDiagnostic test
Participants receive standard physiotherapy exercises aimed at improving motor function, balance, and trunk stability. These exercises include stretching, balance training, and muscle-strengthening activities.
VR + Traditional Physiotherapy GroupCombination product
Participants receive the same physiotherapy exercises as the traditional group, but with additional sessions involving virtual reality exercises. The VR component includes immersive activities that stimulate motor control, coordination, and cognitive engagement to support functional recovery.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group I | Experimental | Not described Receives: Diagnostic Test: Traditional Physiotherapy Group |
| Interventional group II | Active comparator | Not described Receives: Combination Product: VR + Traditional Physiotherapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
Assesses balance and stability.- *Purpose*: Assesses balance in older adults and individuals with balance disorders.
- *Items*: 14 tasks, such as sitting, standing, reaching, and turning.
- *Scoring*: Each task is scored on a scale of 0-4 (0 = inability to perform the task, 4 = normal performance).
- *Total Score*: The maximum score is 56. Higher scores indicate better balance. A score below 45 indicates a higher risk of falling.
Measured: 12 Months
Trunk Impairment Scale (TIS)
Measures trunk control and stability. SF-12 Health Survey: Evaluates quality of life in physical and mental health domains.The *Trunk Impairment Scale (TIS)* is a clinical tool used to assess trunk performance in individuals, particularly those with neurological impairments like stroke. It measures three key aspects: *static sitting balance, dynamic sitting balance, and coordination of trunk movements. The scale consists of **17 items*, with scores ranging from 0 to 23. Higher scores indicate better trunk control and stability. It helps clinicians evaluate and track improvements in trunk function over time, guiding rehabilitation interventions.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start28 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739902
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/770
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Traditional Physiotherapy Combined With Virtual Reality for Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT06739902
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/770
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Dec 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.
This study aims to evaluate the effectiveness of combining virtual reality (VR) therapy with traditional physiotherapy in post-stroke rehabilitation. Post-stroke patients often suffer from impairments in motor function, balance, and overall quality of life. While traditional physiotherapy is a widely accepted method for stroke recovery, incorporating VR technology may enhance treatment outcomes by providing an engaging, immersive environment that motivates patients to perform therapeutic movements.
Detailed description
This study will compare the functional and quality-of-life improvements in patients undergoing traditional physiotherapy alone versus those receiving a combination of conventional physiotherapy and VR interventions. By assessing changes in motor function, trunk stability, balance, and quality of life, this research will provide valuable insights into whether VR can be an effective adjunctive tool in post-stroke rehabilitation programs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group I | Experimental | Diagnostic Test: Traditional Physiotherapy Group |
| Interventional group II | Active comparator | Combination Product: VR + Traditional Physiotherapy Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stroke, either ischemic or hemorrhagic
- Participants who can ambulate independently or with minimal assistance.
- Participants who were willing \& able to adhere to the study protocol.
- Including participants who were attending follow-up appointments \& completing outcome measures.
- Participants who were able to understand \& provide written informed consent
Key exclusion criteria (4 listed)
- Existence of additional neurological disorders (such as multiple sclerosis or Parkinson's disease) or serious medical conditions that could prevent participants from participating in the study.
- Participants receiving rehabilitation or rigorous physical treatment in the previous three months were excluded.
- Pregnant women or breastfeeding women.
- Participants who refused to participate in the study or provide informed consent.
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 |
|---|---|---|
| Traditional Physiotherapy GroupParticipants receive standard physiotherapy exercises aimed at improving motor function, balance, and trunk stability. These exercises include stretching, balance training, and muscle-strengthening activities. | Diagnostic test | Interventional group I |
| VR + Traditional Physiotherapy GroupParticipants receive the same physiotherapy exercises as the traditional group, but with additional sessions involving virtual reality exercises. The VR component includes immersive activities that stimulate motor control, coordination, and cognitive engagement to support functional recovery. | Combination product | Interventional group II |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 12 Months
Assesses balance and stability.- *Purpose*: Assesses balance in older adults and individuals with balance disorders. * *Items*: 14 tasks, such as sitting, standing, reaching, and turning. * *Scoring*: Each task is scored on a scale of 0-4 (0 = inability to perform the task, 4 = normal performance). * *Total Score*: The maximum score is 56. Higher scores indicate better balance. A score below 45 indicates a higher risk of falling.
Trunk Impairment Scale (TIS)
Time frame: 12 Months
Measures trunk control and stability. SF-12 Health Survey: Evaluates quality of life in physical and mental health domains.The *Trunk Impairment Scale (TIS)* is a clinical tool used to assess trunk performance in individuals, particularly those with neurological impairments like stroke. It measures three key aspects: *static sitting balance, dynamic sitting balance, and coordination of trunk movements. The scale consists of **17 items*, with scores ranging from 0 to 23. Higher scores indicate better trunk control and stability. It helps clinicians evaluate and track improvements in trunk function over time, guiding rehabilitation interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physiotherapy Group and VR + Traditional Physiotherapy Group in people with Stroke, run by Superior University 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
Berg Balance Scale (BBS) (time frame: 12 Months). 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?
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 18 Dec 2024.