- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06582394
Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors
August 30, 2024 updated by: Muhammad Naveed Babur, Superior University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The study's main aim is to check virtual reality's effect on conservative treatment in hemiparetic stroke patients.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Lahore, Punjab, Pakistan
- Depalpur
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both ischemia and hemorrhagic stroke.
- Stroke Patients who were in Chronic phase diagnosed by Physician were included in the study.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
|
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.
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|
Experimental: Exp Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
May 1, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
August 21, 2024
First Submitted That Met QC Criteria
August 30, 2024
First Posted (Actual)
September 3, 2024
Study Record Updates
Last Update Posted (Actual)
September 3, 2024
Last Update Submitted That Met QC Criteria
August 30, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/738
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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