Clinical trial NCT06308341: Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy in Post Stroke Patients
Official title: Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy on Balance, Motor Function and Activities of Daily Living in Post Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Activities of Daily Living
Stroke
Motor Control
Randomized Clinical Trial
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke a devastating neurological condition, causing severe neurological challenges such as balance issues, motor function and cognitive deficits among survivors and can cause disability and death. The use of Virtual Reality and Motor Imagery in rehabilitation of neurologic disorders is on the rise. In stroke patients, VR and MI combination has not been studied. This study aims to investigate the combined effects of Virtual Reality and Motor Imagery Techniques with Routine Physical Therapy in patients with post stroke patients.

Detailed description: This randomized control trial will be conducted at Safi Hospital Faisalabad in 7 months after the approval of synopsis, involving a sample size of 75 participants selected through convenience sampling based on the inclusion criteria. Participants will be randomly assigned to three groups using lottery method, in which Group A, will receive Virtual Reality and Motor Imagery training in conjunction with routine physical therapy three days a week for 12 weeks. Group B will receive VR and routine physical therapy, supplemented by 10-15 minutes of cycling and walking and Group C will receive routine physical therapy with MI techniques, along with 10-15 minutes of cycling and walking.

Fugal-Meyer Scale will be used to motor function, Berg Balance Scale for balance and Barthel Index will be used to assess activities of daily living. Assessment will be carried out at baseline, 6th week, 8th week and at 12th week and at 16th week after the discontinuation of treatment. The data will be entered and analyzed by using SPSS 26

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of stroke of any etiology
2. Age between 40 to 65 years
3. Both genders
4. At least 6 months post-stroke onset
5. Able to follow and understand visual and verbal commands.
6. Hemiparetic
7. No prior experience with VR-based rehabilitation.
8. Able to walk with the use of walking aids or assistive devices.
9. Mini-Mental State Examination (MMSE) score equal to or greater than 24

Exclusion Criteria:

1. Presence of aphasia, apraxia, and hemineglect
2. Serious cardiovascular disease (heart failure, arrhythmias, angina pectoris or myocardial infarction)
3. Cerebellar lesion
4. Multiple brain accidents
5. Muscular disorder effect upper and lower extremities
6. History of seizures or epilepsy.
7. Patients whose injury occurred fewer than 6 months previously, considering the expected time for spontaneous recovery;
8. Patients with associated disorders such as epilepsy, and sensory and perceptual deficits such as hemineglect and Pusher syndrome;
9. Patients with osteo degenerative disorders that would prevent participation in the games or that could influence the body balance; and individuals who had cognitive and communication disorders, affecting understanding, that could compromise performance in the games
10. Inability to commit to the study schedule or attend the required therapy sessions

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 16 weeks
measure: Fugal-Meyer Scale
timeFrame: 16 weeks
measure: Barthel Index
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif, PhD-PT
role: STUDY_CHAIR
References:
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