## Protocol Section
### Identification Module
**NCT ID:** NCT06422754

**Brief Title:** 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

#### Organization Study ID Info
**ID:** GaziosmanpasaTREH-FTR-EK-01
#### Organization
**Class:** OTHER_GOV
**Full Name:** Gaziosmanpasa Research and Education Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-29

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Gaziosmanpasa Research and Education Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Hemiplegia

**Keywords:**

- virtual reality

- hemiplegia

- sitting balance

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Becure GmbH

**Label:** Conventional Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: Becure GmbH

**Label:** Virtual Reality Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Conventional Group

- Virtual Reality Group

**Description:** Becure Balance System

**Name:** Becure GmbH

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.

**Measure:** modified ashworth scale

**Time Frame:** 1 month

**Description:** The Brunnstrom recovery stages (BRS) is a short and easily administered measure for assessing motor function.

**Measure:** Brunnstrom Stages

**Time Frame:** 1 month

**Description:** 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.

**Measure:** stroke-specific quality of life

**Time Frame:** 1 month

**Description:** 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).

**Measure:** beck anxiety inventory

**Time Frame:** 1 month

**Description:** The instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.

**Measure:** The Functional Independence Measure

**Time Frame:** 1 month

**Description:** 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.

**Measure:** mini mental state examination

**Time Frame:** 1 month

**Description:** It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture.

**Measure:** Postural Assessment Scale for Stroke

**Time Frame:** 1 month

**Description:** The Motor Assessment Scale (MAS) is a clinical assessment tool that evaluates eight areas of motor function in recovering stroke patients

**Measure:** Rivermead Motor Assessment Scale

**Time Frame:** 1 month

**Description:** 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.

**Measure:** function in sitting test

**Time Frame:** 1 month

**Description:** The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance.

**Measure:** berg balance scale

**Time Frame:** 1 month

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Email:** ervakahraman@hotmail.com

- **Name:** ERVA KAHRAMAN, MD

- **Phone:** +905392339083

- **Role:** CONTACT

***Contact 2:***

- **Name:** EBRU YILMAZ YALCINKAYA, PROF

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Turkey

**Facility:** Erva Kahraman

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 27036515

**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.

**PMID:** 29620137

**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.

**PMID:** 33639116

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010243

- Term: Paralysis

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9515

- Name: Hemiplegia

- Relevance: HIGH

- As Found: Hemiplegia

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006429

- Term: Hemiplegia

### Misc Info Module

- Version Holder: 2024-05-31
