Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422754
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA A RANDOMIZED CONTROLLED STUDY
Sponsor:
Gaziosmanpasa Research and Education Hospital
Organization:
Gaziosmanpasa Research and Education Hospital
Study Overview
Official Title:
THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA A RANDOMIZED CONTROLLED STUDY
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 weekThe 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 01052024-01082024 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
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 weekThe 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 01052024-01082024 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None