Clinical trial NCT04797598: Effects of Virtual Reality and Cyclic Training on Balance
Official title: Effects of Virtual Reality and Cyclic Training on Balance in Sub-acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: Stroke
Virtual Reality
Cyclic Training
Active Video gaming
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 technique
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Berg Balance scale
timeFrame: 12 weeks
measure: Time up and Go
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Asif A Javed, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.