- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06459570
Efficacy of VR Based Sword Fighting Exercises to Improve Upper Body Movements in Hemiplegic Patients
June 10, 2024 updated by: Muhammad Naveed Babur, Superior University
this thesis endeavors to shed light on the efficacy of VR-based sword-fighting exercises as a rehabilitation tool for improving upper body movement in hemiplegic patients.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
By amalgamating clinical insights, technological advancements, and theoretical frameworks, this research aims to contribute to the growing body of knowledge in neurorehabilitation and pave the way for innovative, effective, and engaging interventions to enhance the lives of individuals affected by hemiplegia.
Study Type
Interventional
Enrollment (Actual)
62
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
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Azra Naheed Medical College, Superior University
-
-
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:
- Age 21-80 years
- First clinical stroke, ischemic or hemorrhagic, with diagnosis of stroke confirmed on CT/MRI brain scan.
- Less than 6 weeks after stroke onset
- Upper limb weakness of Medical Research Council (MRC) motor power of grade 2-4 motor power in either the shoulder, elbow or the fingers of the hemiplegic upper extremity
- Subject can understand simple instructions and learn
Exclusion Criteria:
- Recurrent stroke
- History of epilepsy
- Presence of arthritis or pain in the affected upper limb restricting repetitive exercises
- Severe aphasia or cognitive impairment, or other psychiatric illnesses that limit the ability to participate or give consent.
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 |
|---|---|
|
Experimental: Virtual reality based exercises
|
one experimental group with Virtual reality-based exercises.
Subjects in the VR-based exercises will receive 12 sessions of the VR-based exercises treatment, administered four times a week over 3 weeks, with each session lasting approximately 60 minutes.
|
|
Other: standard physical therapy
|
"Second control group with standard physical therapy and occupational therapy treatment.Subjects in the control group will receive 12 sessions of physical therapy treatment involving passive and active range of motion exercises, muscle strengthening, and therapeutic stretching, administered four times a week over a span of 3 weeks, with each session lasting approximately 60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment of upper limb (FMA)
Time Frame: 12 Months
|
This measures upper limb impairment and scores from 0 to 66, the higher the score, the less the impairment.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia.
|
12 Months
|
|
Action Research Arm Test (ARAT)
Time Frame: 12 months
|
This measures arm and hand function and ranges from 0 to 57, the higher the score, the better the upper limb function.
The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).
Performance on each item is rated on a 4-point
|
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)
October 1, 2023
Primary Completion (Actual)
May 1, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
June 10, 2024
First Submitted That Met QC Criteria
June 10, 2024
First Posted (Actual)
June 14, 2024
Study Record Updates
Last Update Posted (Actual)
June 14, 2024
Last Update Submitted That Met QC Criteria
June 10, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/729
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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