Effects of Virtual Reality and Cyclic Training on Balance

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT04797598

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

13.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Other: Virtual reality group Other: Cyclic training group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 techniqueIts 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 (Participant)

Masking Description:

Participants will get separate treatment protocols and possible efforts will be put to m ask the both groups about their treatment

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 21, 2021

Actual Primary Completion Date :

Mar 15, 2021

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Virtual Reality group 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 This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment
Active Comparator: Cyclic training group 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 This will receive cyclic training session. both group will receive conventional physical therapy as base line treatment

Arm

Intervention/Treatment

Active Comparator: Virtual Reality group

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

This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment

Active Comparator: Cyclic training group

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

This will receive cyclic training session. both group will receive conventional physical therapy as base line treatment

Outcome Measures

Primary Outcome Measures

Berg Balance scale [12 weeks]
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 [12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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