StrokeNCT05570032
Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients
A study testing Virtual Reality Training in people with Stroke, run by Dr. Hazrat Bilal PT at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Oct 2021to 25 Feb 2022
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Virtual Reality Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TrainingDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| virtual reality training | Experimental | 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). Receives: Device: Virtual Reality Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
TUG test
Objective of the TUG test is to determine fall risk and measure the progress of balance, sit to stand and walking.
Measured: 8 weeks
MAS scale
The Motor Assessment Scale (MAS) is a performance-based scale used to assess level of impairment and everyday motor function in patients with stroke.
Measured: 8 weeks
Forward stepping test
Forward stepping test is used to assess the balance of the patients with stroke or other neurological disorder.
Measured: 8 weeks
Functional reach test
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start4 Oct 2021
- Primary completion12 Feb 2022
- Study completion25 Feb 2022
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Hazrat Bilal PT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Hazrat Bilal PT, NCS University System
- Investigators
- Shakir Ullah, MSPT, Principal investigator, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570032
- Sponsor's protocol ID
- KMU/IPMR/VR
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT05570032
- Acronym / sponsor ID
- KMU/IPMR/VR
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. Hazrat Bilal PTUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 6 Oct 2022 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| virtual reality training | Experimental | Device: Virtual Reality TrainingIn 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). |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Virtual Reality TrainingIn 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). | Device | virtual reality training |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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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.
Shakir Ullah, MSPT principal investigator
Khyber Medical University Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Training in people with Stroke, run by Dr. Hazrat Bilal PT 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 12 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TUG test (time frame: 8 weeks). The study lists 4 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 12 Oct 2022.