An interventional study of Becure GmbH in Hemiplegia, sponsored by Gaziosmanpasa Research and Education Hospital. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Gaziosmanpasa Research and Education Hospital · Not applicable, Interventional, and Treatment
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.
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.
390 studies on the registry are indexed under Hemiplegia; 87 are open to participants now.
This study's planned enrollment of 36 is close to the median of 36 across 322 interventional studies indexed under Hemiplegia.
Browse Hemiplegia studies →Gaziosmanpasa Research and Education Hospital is the lead sponsor of 125 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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
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
Becure Balance System
modified ashworth scale
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.
Time frame: 1 month
Brunnstrom Stages
The Brunnstrom recovery stages (BRS) is a short and easily administered measure for assessing motor function.
Time frame: 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.
Time frame: 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).
Time frame: 1 month
The Functional Independence Measure
The instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 1 month
berg balance scale
The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance.
Time frame: 1 month
Plan to share: No
Started Apr 2024 (actual). Primary completion is estimated for Aug 2024, 3 months after the start.
Of 190 non-industry interventional studies with no phase under Hemiplegia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 3 months is below that.
Counting every sponsor, half of 197 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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