- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05570032
Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients
October 9, 2022 updated by: Dr. Hazrat Bilal PT
Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients: A Quasi-experimental Study
This single group quasi-experimental study was conducted at Rafsan Neuro Rehab Center, Peshawar from October 2021 to February 2022.
The sample size of study was 40 post stroke patients who were diagnosed on physical findings and other investigation like CT and MRI.
The inclusion criteria were set as post-stroke patients for more than 3 months with 20 and above score on MAS scale and age of 55 to 65 years, while the exclusion criteria were defined as participants having traumatic brain injuries, degenerative brain diseases, post craniotomy tumor patients leading to hemiplegia, patients having recurrent episodes of stroke, stroke patient with dementia and score on MAS scale below 20.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
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
-
-
Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Hazrat Bilal
-
-
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
55 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The inclusion criteria were set as post-stroke patients for more than 3 months
- 20 and above score on MAS scale
- age of 55 to 65 years
Exclusion Criteria:
- The exclusion criteria were defined as
- participants having traumatic brain injuries, degenerative brain diseases, post craniotomy tumor patients leading to hemiplegia,
- patients having recurrent episodes of stroke,
- stroke patient with dementia
- score on MAS scale below 20.
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: virtual reality training
In intervention the participants took part in the VR training.
The X-BOX 360 (Augmented virtual reality) device was used.
The participants were guided about the virtual reality training including Kinect sports gamming (Trail 1. badminton, beach volley ball, Soccer goal keeping).
Each training was performed for 15 minutes with 5 minutes break time.
The whole training was performed for 8 weeks.
After eight weeks final assessment was done through outcome measuring tools (TUG test, MAS scale, forward stepping test and Functional reach test).
|
In intervention the participants took part in the VR training.
The X-BOX 360 (Augmented virtual reality) device was used.
The participants were guided about the virtual reality training including Kinect sports gamming (Trail 1. badminton, beach volley ball, Soccer goal keeping).
Each training was performed for 15 minutes with 5 minutes break time.
The whole training was performed for 8 weeks.
After eight weeks final assessment was done through outcome measuring tools (TUG test, MAS scale, forward stepping test and Functional reach test).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TUG test
Time Frame: 8 weeks
|
Objective of the TUG test is to determine fall risk and measure the progress of balance, sit to stand and walking.
|
8 weeks
|
|
MAS scale
Time Frame: 8 weeks
|
The Motor Assessment Scale (MAS) is a performance-based scale used to assess level of impairment and everyday motor function in patients with stroke.
|
8 weeks
|
|
Forward stepping test
Time Frame: 8 weeks
|
Forward stepping test is used to assess the balance of the patients with stroke or other neurological disorder.
|
8 weeks
|
|
Functional reach test
Time Frame: 8 weeks
|
The Functional reach test assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shakir Ullah, MSPT, Khyber Medical University Peshawar
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 4, 2021
Primary Completion (Actual)
February 12, 2022
Study Completion (Actual)
February 25, 2022
Study Registration Dates
First Submitted
September 26, 2022
First Submitted That Met QC Criteria
October 3, 2022
First Posted (Actual)
October 6, 2022
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 9, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMU/IPMR/VR
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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