Clinical trial NCT06509698: Comparative Effects of Virtual Reality and Frenkel's Exercises in Patients With Stroke.
Official title: Comparative Effects of Virtual Reality and Frenkel's Exercises on Balance, Gait and Quality of Life in Patients With Stroke.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Balance
Berg balance scale
Frenkel's exercises
gait
stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 36
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: To compare the effects of Virtual reality and Frenkel's exercises on balance, gait and quality of life in patients with stroke.

Detailed description: This randomized Control trial will be conducted at Islam central hospital, Sialkot over a duration of 7 months after approval of synopsis. 36 Participants who meet the inclusion criteria will be further divided into 2 groups. The treatment will be given with the frequency of 3 times per week for 6 weeks. Treatment sessions will be of 30 minutes with short resting intervals. Data will be collected using various assessment tools including, berg balance scale, time-up and stroke-specific quality of life. Pre-intervention assessment will be conducted before starting the treatment protocol and post assessment after 6 weeks of treatment. The data will be analyzed using SPSS version 28 for Windows software. Statistical significance will be set at p = 0.05. Normality of data will be assessed through Kolmogorov Smirnov test. Difference between pre-treatment and post-treatment readings will be calculated using Paired sample t-test for parametric data. For non-parametric data Wilcoxon test will be used. Independent sample t-test will be used for parametric data and Mann Whitney test will be used for non-parametric data.

Eligibility criteria: Inclusion Criteria:

1- Age 40-65 years. 2. Stroke patients with both genders. 3. Subacute stroke patients will be included. 4. Survivors of ischemic stroke. 5. No prior experience with VR-based rehabilitation. 6. Patients with ≥24 Mini-Mental State Exam score.

Exclusion Criteria:

1. Patient with serious behavioral problems or mental health.
2. Patients with recent lower extremity deep vein thrombosis, quadriplegia, Parkinson's disease, lower limb fractures, or recent myocardial infarction.
3. Patients with malignant tumor, or other unstable condition.
4. Participants with ENT defect, hearing, majorly affected vision(blindness), cataract, glaucoma, loss of vision.
5. Subjects with diagnosed vestibular disease.

Primary outcomes:
measure: berg balance scale
timeFrame: 6-weeks
measure: time up and go
timeFrame: 6-weeks
measure: stroke specific quality of life
timeFrame: 6-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Alveena fatima
state: Punjab
Study officials:
affiliation: Riphah International University
name: Alveena Fatima, Ms.NMPT
role: PRINCIPAL_INVESTIGATOR
References:
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