Comparative Effects of Virtual Reality and Frenkel's Exercises in Patients With Stroke.

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: virtual reality; Other: Frenkel's exercise

• Registration Number: NCT06509698
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2024-02-20
• Status Verified: 2024-07
• Primary Completion: 2024-07-12
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Study Completion: 2024-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
virtual reality	virtual reality	Virtual reality used for balance, gait and quality of life the treatment will be given with the frequency of 3 times per week for 6 weeks. Warmup period, Instruct the patient/participants, Gaming time (20 minutes), cool down period (5 minutes). Treatment sessions will be of 30 minutes with short resting intervals.
Frenkel's exercise	Frenkel's exercise	Frenkel's exercise used for balance, gait and quality of life Frenkel's exercise, the treatment will be given with the frequency of 3 times per week for 6 weeks. Warmup period (5 minutes), frenkel's exercise (20 minutes), cool down period (5 minutes). Treatment sessions will be of 30 minutes with short resting intervals.

Primary Outcome Measures

Name	Time	Method
berg balance scale	6-weeks	The BBS is an instrument that assesses functional balance performance in older adults using 14 tasks: sitting to standing, standing unsupported, sitting unsupported, standing to sitting, transfers, standing with eyes closed, standing with feet together, reaching forward with outstretched arm, retrieving object from floor, turning to look behind, turning 360 degrees, placing the foot alternately on a step, standing with 1 foot in front, and standing on 1 foot.18 The maximum score is 56 points, representing normal balance. Each item is scored from 0 (unable to perform) to 4 (normal performance)
time up and go	6-weeks	A straightforward performance test called the Timed-Up-and-Go (TUG) is frequently used to evaluate stroke patients' functional mobility and may be able to reveal some information on turning movement. The patient was really instructed to get up from a seated posture, walk three metres, turn around 180 degrees, walk three metres back, turn around 180 degrees, and then sit down once again. It is a viable tool to monitor walkable stroke patients because it is an easy-to-administer, quick test with good intra- and inter-rater reliability, strong convergent validity, and sensitivity to modest changes.4. The amount of time the patient needs to do the task in total determines their score. In fact, the TUG integrates several mobility functions, and its various subcomponents include intricate tasks.
stroke specific quality of life	6-weeks	A disease-specific patient-reported outcome measure called the SSQOL was created to evaluate the quality of life for stroke survivors. The 48 items are categorized into 12 domains: job, language, mobility, thinking, personality, mood, family roles, social roles, energy, self-care, vision, and upper extremity function. Each domain has three to six items. Likert scale answers are used for the items, with the least impacted item receiving a score of one and the unaffected item receiving a score of five. The questionnaire has a maximum total score of 245 and a minimum score of 49. A quality of life score of 60% of the maximum value indicates poor life.

Trial Locations

Locations (1)

Alveena fatima; 🇵🇰 Lahore, Punjab, Pakistan