NCT06422754

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

May 21, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

May 15, 2024

Last Update Submit

May 15, 2024

Conditions

Hemiplegia

Keywords

virtual realityhemiplegiasitting balance

Outcome Measures

Primary Outcomes (10)

  • modified ashworth scale

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

    1 month

  • Brunnstrom Stages

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

    1 month

  • 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

  • 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

  • The Functional Independence Measure

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

    1 month

  • 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

  • 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

  • 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

  • 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

  • berg balance scale

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

    1 month

Study Arms (2)

Conventional Group

ACTIVE COMPARATOR

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.

Device: Becure GmbH

Virtual Reality Group

ACTIVE COMPARATOR

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.

Device: Becure GmbH

Interventions

Becure GmbHDEVICE

Becure Balance System

Conventional GroupVirtual Reality Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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).

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erva Kahraman

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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: 27036515BACKGROUND

  • 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: 29620137BACKGROUND

  • 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: 33639116BACKGROUND

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 21, 2024

Study Start

April 29, 2024

Primary Completion

August 1, 2024

Study Completion

August 15, 2024

Last Updated

May 21, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)