Effects of Virtual Reality and Cyclic Training on Balance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Virtual Reality and Cyclic Training on Balance in Sub-acute Stroke

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: Virtual reality group
* Other: Cyclic training group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual Reality group<br>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. | Other: Virtual reality group<br>* This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment<br>|
| Active Comparator: Cyclic training group<br>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 | Other: Cyclic training group<br>* This will receive cyclic training session. both group will receive conventional physical therapy as base line treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Virtual Reality, Cyclic Training, Active Video gaming