Effects of Virtual Reality and Cyclic Training on Balance

NCT04797598 | Completed

• 1 other identifier: REC/LHR/20/2054 Qandil Akram
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

Stroke; Virtual Reality; Cyclic Training; Active Video gaming

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Virtual Reality group

ACTIVE COMPARATOR

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

Cyclic training group

ACTIVE COMPARATOR

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

Interventions

Virtual reality group OTHER

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

Virtual Reality group

Cyclic training group OTHER

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

Cyclic training group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

  PMID: 22019971 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Muhammad Asif A Javed, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to m ask the both groups about their treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: January 21, 2021
• Primary Completion: March 15, 2021
• Study Completion: April 1, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)