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

July 15, 2024 updated by: Riphah International University

Comparative Effects of Virtual Reality and Frenkel's Exercises on Balance, Gait and Quality of Life in Patients With Stroke.

To compare the effects of Virtual reality and Frenkel's exercises on balance, gait and quality of life in patients with stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: virtual reality
STEP I: For the warm-up, the examiner will perform passive stretching exercises to maintain the range of motion. STEP II: The patient will receive the game instructions by the examiner. STEP III: The patient will play the Adventure games and Sport games including tennis, boxing and kicking. virtual reality (20 minutes) using Nintendo Wii®, Wii Fit game will be used to stimulate and reinforce the improvement of balance and gait and enhance the quality of life.(30) Balance game: Soccer Heading, Penguin Slides, Balance Bubble, Torso Twists, and Single Leg Stance. Motor function: Boxing, Kicking, Tennis and Bowling Aerobic Games: 2-P run, advanced step, Title city and Basic Run. Step IV: (cool-down): Same as step one.
Active Comparator: 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.
Other: Frenkel's exercise
Frenkel's activities, which included learning how to turn around, sit down, and get up using a variety of commonplace objects like chairs, beds, or traces drawn on the floor, as well as learning how to walk with upper limb coordination. This is a typical workout regimen used in testing and rehabilitation centers. Patients engaged in the following activities, each activity time is 1.5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
berg balance scale
Time Frame: 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)
6-weeks
time up and go
Time Frame: 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.
6-weeks
stroke specific quality of life
Time Frame: 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.
6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Alveena Fatima, Ms.NMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

July 12, 2024

Study Completion (Estimated)

July 20, 2024

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0284 Aqsa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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