THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY

Not Applicable

Recruiting

• Conditions: Hemiplegia
• Interventions: Device: Becure GmbH

• Registration Number: NCT06422754
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

Objective: The aim of this study was to investigate the effects of virtual reality application on quality of life and functionality, especially sitting balance, in hemiplegic patients.

Detailed Description

This study was planned as a single-blind randomized controlled prospective study. Patients over 18 years of age with a diagnosis of hemiplegia who applied to Gaziosmanpaşa Training and Research Hospital PTR outpatient clinic and were hospitalized in the rehabilitation service and started a rehabilitation program; will be evaluated with Modified Ashworth, Tardiue Scale, Brunstrom assessment, Stroke Specific Quality of Life Scale, Beck Anxiety Scale, Functional Independence Scale, Mini Mental State Test (MMDT), Mini Mental Test for the Uneducated, Postural Assessment Scale in Stroke Patients, Rivermead Motor Assessment Scale, Sitting Function Test, Berg Balance Scale, System Usability Scale before and after the program.

Patients who apply to the rehabilitation program will be randomly selected by closed envelope method. The first group will receive conventional rehabilitation program and home program. Conventional exercises\* of the first group will be performed for 30 sessions of 1 hour every day, in addition to this, the patient will be given a home program.

In the second group, conventional exercises will be performed for 30 sessions of 1 hour every day. In addition to conventional exercises, this group will be enrolled in a balance game group using the Becure Balance System application and the WI balance board for 45 minutes 5 sessions a week.The necessary software and equipment for the virtual reality program were donated by Becure GmbH.

Both groups will be reassessed after 30 sessions. The physician performing the evaluation will be completed blindly by physiotherapists who apply the conventional exercises and the virtual reality program.

The study is a single-center clinical study using prospective data. Between 01.05.2024-01.08.2024, 36 patients are planned to be enrolled in the study.

\*:Conventional exercise therapy includes range of motion, stretching, strengthening and balance exercises in patients with hemiplegia.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-29
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-15

Recruitment & Eligibility

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

Inclusion Criteria

• 1. Stable medical condition 2. Over 18 years of age 3. A score of 23 or above on the mini mental state test (MMDT) or the mini mental state test for the untrained (MMDT-E) 4. Within the period of 1-18 months after stroke 5. A score of 3 or 4 on the 3rd item of the Berg Balance Scale (BBS), which evaluates the balance of sitting without support (3= can sit for 2 minutes under supervision, 4= can sit safely for 2 minutes).

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Exclusion Criteria

• 1. Previous history of stroke 2. Aphasic patients in whom information exchange is not possible 3. Patients with impaired vision, hearing and vestibular system 4. Musculoskeletal and nervous system disorders other than stroke that may cause physical disability 5. Patients with a history of epilepsy 6. Cerebrovascular attack involving more than one hemisphere 7. Presence of cerebellar lesions or impaired cerebellar tests

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Group	Becure GmbH	The first group will receive 30 sessions of conventional exercises for 1 hour every day. In addition, the patient will be given a home program.
Virtual Reality Group	Becure GmbH	In the second group, conventional exercises will be applied for 1 hour and 30 sessions every day. In addition to conventional exercise, this group will be enrolled in the balance game group using the Becure Balance System application and Wİ balance board for 45 minutes 5 sessions a week.

Primary Outcome Measures

Name	Time	Method
Postural Assessment Scale for Stroke	1 month	It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture.
Rivermead Motor Assessment Scale	1 month	The Motor Assessment Scale (MAS) is a clinical assessment tool that evaluates eight areas of motor function in recovering stroke patients
Brunnstrom Stages	1 month	The Brunnstrom recovery stages (BRS) is a short and easily administered measure for assessing motor function.
stroke-specific quality of life	1 month	The QOLS was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation.
beck anxiety inventory	1 month	The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
mini mental state examination	1 month	The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
berg balance scale	1 month	The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance.
modified ashworth scale	1 month	The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.
The Functional Independence Measure	1 month	The instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.
function in sitting test	1 month	The FIST tests balance in seated position. The patient should perform items with their best posture and balance, and while moving in a seated position. The therapist will give them occasional light pushes to test for balance reactions. The therapist will make sure they won't lose their balance.

Trial Locations

Locations (1)

Erva Kahraman; 🇹🇷 Istanbul, Turkey