Clinical trial NCT06422754: THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY
Official title: THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia
Keywords: virtual reality
hemiplegia
sitting balance
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: modified ashworth scale
timeFrame: 1 month
measure: Brunnstrom Stages
timeFrame: 1 month
measure: stroke-specific quality of life
timeFrame: 1 month
measure: beck anxiety inventory
timeFrame: 1 month
measure: The Functional Independence Measure
timeFrame: 1 month
measure: mini mental state examination
timeFrame: 1 month
measure: Postural Assessment Scale for Stroke
timeFrame: 1 month
measure: Rivermead Motor Assessment Scale
timeFrame: 1 month
measure: function in sitting test
timeFrame: 1 month
measure: berg balance scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Erva Kahraman
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.