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

Hemiplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422754
• Other study ID #: GaziosmanpasaTREH-FTR-EK-01
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: April 2024
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 15, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Device:
• Becure GmbH
Becure Balance System

Locations

Country	Name	City	State
Turkey	Erva Kahraman	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified ashworth scale	The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.	1 month
Primary	Brunnstrom Stages	The Brunnstrom recovery stages (BRS) is a short and easily administered measure for assessing motor function.	1 month
Primary	stroke-specific quality of life	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.	1 month
Primary	beck anxiety inventory	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).	1 month
Primary	The Functional Independence Measure	The instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.	1 month
Primary	mini mental state examination	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.	1 month
Primary	Postural Assessment Scale for Stroke	It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture.	1 month
Primary	Rivermead Motor Assessment Scale	The Motor Assessment Scale (MAS) is a clinical assessment tool that evaluates eight areas of motor function in recovering stroke patients	1 month
Primary	function in sitting test	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.	1 month
Primary	berg balance scale	The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance.	1 month