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

NCT ID: NCT06422754

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2024-08-15

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.

Conditions

Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional Group

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.

Group Type: ACTIVE_COMPARATOR

Becure GmbH

Intervention Type: DEVICE

Becure Balance System

Virtual Reality Group

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.

Group Type: ACTIVE_COMPARATOR

Becure GmbH

Intervention Type: DEVICE

Becure Balance System

Interventions

Becure GmbH

Becure Balance System

Intervention Type: DEVICE

Eligibility Criteria

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).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Erva Kahraman

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

ERVA KAHRAMAN, MD

Role: primary

ervakahraman@hotmail.com

+905392339083

References

Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Fergusson D, Levac D, Finestone H. Does the addition of virtual reality training to a standard program of inpatient rehabilitation improve sitting balance ability and function after stroke? Protocol for a single-blind randomized controlled trial. BMC Neurol. 2016 Mar 31;16:42. doi: 10.1186/s12883-016-0563-x.

Reference Type: BACKGROUND

PMID: 27036515 (View on PubMed)

Karasu AU, Batur EB, Karatas GK. Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study. J Rehabil Med. 2018 May 8;50(5):406-412. doi: 10.2340/16501977-2331.

Reference Type: BACKGROUND

PMID: 29620137 (View on PubMed)

Marques-Sule E, Arnal-Gomez A, Buitrago-Jimenez G, Suso-Marti L, Cuenca-Martinez F, Espi-Lopez GV. Effectiveness of Nintendo Wii and Physical Therapy in Functionality, Balance, and Daily Activities in Chronic Stroke Patients. J Am Med Dir Assoc. 2021 May;22(5):1073-1080. doi: 10.1016/j.jamda.2021.01.076. Epub 2021 Feb 24.

Reference Type: BACKGROUND

PMID: 33639116 (View on PubMed)

Other Identifiers

GaziosmanpasaTREH-FTR-EK-01

Identifier Type: -

Identifier Source: org_study_id