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

Last updated: May 15, 2024
Sponsor: Gaziosmanpasa Research and Education Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Limb Spasticity

Treatment

Becure GmbH

Clinical Study ID

NCT06422754
GaziosmanpasaTREH-FTR-EK-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Previous history of stroke 2. Aphasic patients in whom information exchange isnot possible 3. Patients with impaired vision, hearing and vestibular system 4.Musculoskeletal and nervous system disorders other than stroke that may causephysical disability 5. Patients with a history of epilepsy 6. Cerebrovascularattack involving more than one hemisphere 7. Presence of cerebellar lesions orimpaired cerebellar tests

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Becure GmbH
Phase:
Study Start date:
April 29, 2024
Estimated Completion Date:
August 15, 2024

Study 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.

Connect with a study center

  • Erva Kahraman

    Istanbul,
    Turkey

    Active - Recruiting

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