Effects of Virtual Reality and Cyclic Training on Balance

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797598
• Other study ID #: REC/LHR/20/2054 Qandil Akram
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: May 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 1, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• Virtual reality group
This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment
• Cyclic training group
This will receive cyclic training session. both group will receive conventional physical therapy as base line treatment

Locations

Country	Name	City	State
Pakistan	Riphah International University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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