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Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Virtual Reality Training
Sponsored by
Dr. Hazrat Bilal PT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hazrat Bilal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

virtual reality training

Arm Description

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).

Outcomes

Primary Outcome Measures

TUG test
Objective of the TUG test is to determine fall risk and measure the progress of balance, sit to stand and walking.
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.
Forward stepping test
Forward stepping test is used to assess the balance of the patients with stroke or other neurological disorder.
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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2022
Last Updated
October 9, 2022
Sponsor
Dr. Hazrat Bilal PT
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1. Study Identification

Unique Protocol Identification Number
NCT05570032
Brief Title
Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients
Official Title
Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients: A Quasi-experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
February 12, 2022 (Actual)
Study Completion Date
February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Hazrat Bilal PT

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality training
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Virtual Reality Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
TUG test
Description
Objective of the TUG test is to determine fall risk and measure the progress of balance, sit to stand and walking.
Time Frame
8 weeks
Title
MAS scale
Description
The Motor Assessment Scale (MAS) is a performance-based scale used to assess level of impairment and everyday motor function in patients with stroke.
Time Frame
8 weeks
Title
Forward stepping test
Description
Forward stepping test is used to assess the balance of the patients with stroke or other neurological disorder.
Time Frame
8 weeks
Title
Functional reach test
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakir Ullah, MSPT
Organizational Affiliation
Khyber Medical University Peshawar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hazrat Bilal
City
Peshawar
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

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Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients

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