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NCT Number: NCT06509698

Comparative Effects of Virtual Reality and Frenkel's Exercises 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Virtual Reality

Other

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.

Frenkel's Exercise

Other

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

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alveena Fatima, Ms.NMPT

CONTACT

[email protected]

03111231810

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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