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Effects of Virtual Reality and Cyclic Training on Balance

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Virtual reality group
Cyclic training group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Stroke, Virtual Reality, Cyclic Training, Active Video gaming

Eligibility Criteria

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

Inclusion Criteria:

  1. Sub-acute stroke
  2. Able to stand for 5 minutes
  3. The score of mini mental state examination (MMSE) > 19
  4. Male and Females (both genders)
  5. Verbal instructions can follow

Exclusion Criteria:

  1. Visual and auditory problem unable to hear and see feedback from the video game and problem of vestibular system
  2. Spasticity of lower limb
  3. Any other medical condition that could affect movement and balance
  4. Use of pacemaker, apraxia, epilepsy
  5. Psychiatric disorders

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Virtual Reality group

Cyclic training group

Arm Description

In this group patients will be treated with virtual reality . This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24. The virtual reality group will receive 30 minutes virtual reality training and 30 minutes conventional treatment.

In this group patients will be treated with cyclic training . This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24. The cyclic training group will receive 30 minutes cyclic training and 30 minutes conventional treatment

Outcomes

Primary Outcome Measures

Berg Balance scale
this tool is used for assessing change from baseline .14 item scale designed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.it is a 14 item scale list with each item consisting of a five point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function. BBS have high validity and reliability of 0.98 41 -56= low fall risk 21-40 = medium fall risk 0-20 = high risk
Time up and Go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. Interpretation: ≤ 10 seconds = normal. ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid. ≤ 30 seconds = problems, cannot go outside alone, requires gait aid. * A score of ≥ 14 seconds has been shown to indicate high risk of falls.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2021
Last Updated
May 7, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04797598
Brief Title
Effects of Virtual Reality and Cyclic Training on Balance
Official Title
Effects of Virtual Reality and Cyclic Training on Balance in Sub-acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
Stroke is the third leading cause of functional disability and death in the world. It leads to many problems that affect gait, upper extremity function and balance. In stroke patients balance dysfunction leads to impaired postural control and walking. Because of poor balance fall rate increases in stroke patients. Balance is an important predictor of outcome in stroke rehabilitation. After stroke difficulties in balance control may be caused by multiple factors such as muscle weakness, impaired proprioception, and asymmetry in weight wearing, spasticity and impaired motor control. Different means are used to treat stroke, some conventional treatments along with new adjunct therapies are usual practice for the rehabilitation of the stroke. Virtual Reality is choice of adjunct therapy now a days and can be used in different ways for the rehabilitation. Virtual Reality or active video gaming proved their role as vital part of the treatment program in pediatric rehabilitation as well as adult rehabilitation program. These programs help the patient to achieve goals for functional and activities of daily living skills.
Detailed Description
This study will be a randomized control trial, used to compare the effectiveness of virtual reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique. Assessment will be done by using berg balance scale (BBS) and time up and go test. Subjects in one group will be treated with Virtual reality and Conventional therapy and in other group Cyclic training and Conventional therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Stroke, Virtual Reality, Cyclic Training, Active Video gaming

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Its a randomized control trial, used to compare the effects of virtual reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique
Masking
Participant
Masking Description
Participants will get separate treatment protocols and possible efforts will be put to m ask the both groups about their treatment
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality group
Arm Type
Active Comparator
Arm Description
In this group patients will be treated with virtual reality . This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24. The virtual reality group will receive 30 minutes virtual reality training and 30 minutes conventional treatment.
Arm Title
Cyclic training group
Arm Type
Active Comparator
Arm Description
In this group patients will be treated with cyclic training . This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24. The cyclic training group will receive 30 minutes cyclic training and 30 minutes conventional treatment
Intervention Type
Other
Intervention Name(s)
Virtual reality group
Intervention Description
This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment
Intervention Type
Other
Intervention Name(s)
Cyclic training group
Intervention Description
This will receive cyclic training session. both group will receive conventional physical therapy as base line treatment
Primary Outcome Measure Information:
Title
Berg Balance scale
Description
this tool is used for assessing change from baseline .14 item scale designed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.it is a 14 item scale list with each item consisting of a five point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function. BBS have high validity and reliability of 0.98 41 -56= low fall risk 21-40 = medium fall risk 0-20 = high risk
Time Frame
12 weeks
Title
Time up and Go
Description
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. Interpretation: ≤ 10 seconds = normal. ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid. ≤ 30 seconds = problems, cannot go outside alone, requires gait aid. * A score of ≥ 14 seconds has been shown to indicate high risk of falls.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sub-acute stroke Able to stand for 5 minutes The score of mini mental state examination (MMSE) > 19 Male and Females (both genders) Verbal instructions can follow Exclusion Criteria: Visual and auditory problem unable to hear and see feedback from the video game and problem of vestibular system Spasticity of lower limb Any other medical condition that could affect movement and balance Use of pacemaker, apraxia, epilepsy Psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Asif A Javed, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22019971
Citation
Yang S, Hwang WH, Tsai YC, Liu FK, Hsieh LF, Chern JS. Improving balance skills in patients who had stroke through virtual reality treadmill training. Am J Phys Med Rehabil. 2011 Dec;90(12):969-78. doi: 10.1097/PHM.0b013e3182389fae.
Results Reference
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Effects of Virtual Reality and Cyclic Training on Balance

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