Effects of Virtual Reality and Cyclic Training on Balance

NCT ID: NCT04797598

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2021-04-01

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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Virtual reality group

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Cyclic training group

Intervention Type: OTHER

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

Interventions

Virtual reality group

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

Intervention Type: OTHER

Cyclic training group

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Asif A Javed, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 22019971 (View on PubMed)

Other Identifiers

REC/LHR/20/2054 Qandil Akram

Identifier Type: -

Identifier Source: org_study_id