StrokeNCT06582394
Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors
A study testing Exp Group in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
In hemiparetic stroke patient's VR is very useful. Due to hemiparesis one side muscle weakness occurs because of disruption in brain, spinal cord and nervous system technologies improvs motor activities of patients, by improvement in motor activities patients perform activities in better way. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Exp Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Oct 2024
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both ischemia and hemorrhagic stroke.
- Stroke Patients who were in Chronic phase diagnosed by Physician were included in the study.
Who cannot join
- Patient with the history of previous stroke attacks.
- Brainstem stroke
- Epilepsy
- Severely impaired communication and cognition
- Parkinson's disease and multiple sclerosis
- Other musculoskeletal and psychological disorder
Trial locations and contacts
1 site in 1 country.
About this study
In hemiparetic stroke patient's VR is very useful. Due to hemiparesis one side muscle weakness occurs because of disruption in brain, spinal cord and nervous system technologies improvs motor activities of patients, by improvement in motor activities patients perform activities in better way.
Read the detailed description
The study's main aim is to check virtual reality's effect on conservative treatment in hemiparetic stroke patients.
- Conditions
- Stroke
- Being tested
- Exp Group, Control group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exp GroupCombination product
Balance and coordination were targeted through virtual stepping tasks, where participants practiced stepping in various directions to improve postural control and lower limb function. Additionally, they performed virtual balance exercises by standing on simulated platforms of varying stability. For gait and mobility, participants practiced walking in a virtual environment with real-time feedback to correct gait abnormalities. They also encountered virtual obstacles, which required them to adapt their walking patterns and improve mobility. In this study, both the intervention and control groups underwent a 6-week treatment plan consisting of 5 sessions per week, with each session lasting 45 minutes.
Control groupOther
For gait training, participants practiced walking on flat surfaces, sometimes with the assistance of parallel bars or walking aids, to improve their walking speed, step length, and rhythm. They also performed sit-to-stand exercises to strengthen the lower limbs and improve mobility for daily activities. Additionally, manual therapy techniques, such as joint mobilizations and stretching, were applied to reduce spasticity and increase range of motion in the affected limbs. Both treatment groups progressed based on individual capabilities, with therapists adjusting exercises accordingly throughout the study. In this study, both the intervention and control groups underwent a 6-week treatment plan consisting of 5 sessions per week, with each session lasting 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exp Group | Experimental | Not described Receives: Combination Product: Exp Group |
| Control Group | Active comparator | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index
The Barthel Index is a scale used to measure a person's ability to perform basic activities of daily living (ADL) independently. It assesses 10 areas of functioning, with a focus on mobility and self-care. Scores range from 0 to 100, with higher scores indicating greater independence. Stroke-Specific Quality of Life Scale (SS-QOL) It assesses the impact of stroke on the quality of life across various domains, including physical, emotional, social, and cognitive aspects. It uses 12 domains with items scored on a 5-point Likert scale
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 posted3 Sep 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion30 Oct 2024 (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
- 30 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
- NCT06582394
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/738
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 3 Sep 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors
- ClinicalTrials.gov ID
- NCT06582394
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/738
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- 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.
In hemiparetic stroke patient's VR is very useful. Due to hemiparesis one side muscle weakness occurs because of disruption in brain, spinal cord and nervous system technologies improvs motor activities of patients, by improvement in motor activities patients perform activities in better way.
Detailed description
The study's main aim is to check virtual reality's effect on conservative treatment in hemiparetic stroke patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exp Group | Experimental | Combination Product: Exp Group |
| Control Group | Active comparator | Other: Control group |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both ischemia and hemorrhagic stroke.
- Stroke Patients who were in Chronic phase diagnosed by Physician were included in the study.
Key exclusion criteria (6 listed)
- Patient with the history of previous stroke attacks.
- Brainstem stroke
- Epilepsy
- Severely impaired communication and cognition
- Parkinson's disease and multiple sclerosis
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 |
|---|---|---|
| Exp GroupBalance and coordination were targeted through virtual stepping tasks, where participants practiced stepping in various directions to improve postural control and lower limb function. Additionally, they performed virtual balance exercises by standing on simulated platforms of varying stability. For gait and mobility, participants practiced walking in a virtual environment with real-time feedback to correct gait abnormalities. They also encountered virtual obstacles, which required them to adapt their walking patterns and improve mobility. In this study, both the intervention and control groups underwent a 6-week treatment plan consisting of 5 sessions per week, with each session lasting 45 minutes. | Combination product | Exp Group |
| Control groupFor gait training, participants practiced walking on flat surfaces, sometimes with the assistance of parallel bars or walking aids, to improve their walking speed, step length, and rhythm. They also performed sit-to-stand exercises to strengthen the lower limbs and improve mobility for daily activities. Additionally, manual therapy techniques, such as joint mobilizations and stretching, were applied to reduce spasticity and increase range of motion in the affected limbs. Both treatment groups progressed based on individual capabilities, with therapists adjusting exercises accordingly throughout the study. In this study, both the intervention and control groups underwent a 6-week treatment plan consisting of 5 sessions per week, with each session lasting 45 minutes. | Other | Control Group |
Primary outcome
Barthel index
Time frame: 12 Months
The Barthel Index is a scale used to measure a person's ability to perform basic activities of daily living (ADL) independently. It assesses 10 areas of functioning, with a focus on mobility and self-care. Scores range from 0 to 100, with higher scores indicating greater independence. Stroke-Specific Quality of Life Scale (SS-QOL) It assesses the impact of stroke on the quality of life across various domains, including physical, emotional, social, and cognitive aspects. It uses 12 domains with items scored on a 5-point Likert scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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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
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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.
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 Exp 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 2 inclusion and 6 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 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?
Results are not available in the source record.
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?
Barthel index (time frame: 12 Months). 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 3 Sep 2024.