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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05993624
Other study ID # ELMIRAHASRET
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 17, 2023
Est. completion date June 17, 2023

Study information

Verified date August 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study included 15 geriatric individuals over the age of 65 staying in Kızılay Zeynep Nedim Oyvar Nursing Home and Elderly Nursing Home. Participants in the study were rehabilitated by playing exergame games with Xbox 360 KinectTM for 30 minutes once a week for 8 weeks. Before starting the application, the participants were given a demographic information form, Tampa kinesiophobia scale for kinesiophobia, Nintendo Wii balance platform and basic balance game for balance measurement, geriatric depression scale-short form for depression, cognitive functions, and mini-mental state test for the lower extremities. functional strength and risk of falling. The shuttle test was applied 5 times. These tests will be repeated at the end of 8 sessions and before and after values were measured. As a result of the analysis, the effects of Xbox 360 KinectTM games on kinesiophobia, balance, lower extremity muscle strength, depression, and cognitive functions in geriatric individuals with kinesiophobia were investigated.


Description:

15 geriatric individuals over 65 years old living in Kızılay Zeynep Nedim Oyvar Nursing Home and Elderly Care Center were included in the study. The ethics committee of Istanbul Gedik University Ethics Committee, dated 17/01/2023 and numbered E-56365223-050.01.04-2023.137548.27-433, was accepted. A consent form was signed by geriatric individuals who met the conditions of this study. Participants participating in the study played 30 minutes of exergame games once a week for 8 weeks and rehabilitation was applied. Before starting the application, participants were given a demographic information form, Tampa kinesiophobia scale for kinesiophobia, BeCure balance assessment system for balance measurement, geriatric depression scale-short form for depression, mini-mental state test for cognitive functions, and lower extremity functional strength and risk of falling 5 times. lift test was applied. These tests were repeated at the end of 8 sessions and before and after values were measured.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date June 17, 2023
Est. primary completion date April 5, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Getting 38 or higher on the Tampa Kinesiophobia Scale - Getting a Mini Mental State Test Score of 20 and above - Being physically competent to apply the scales to be used - Being 65 years or older - Volunteering to work Exclusion Criteria: - Having a mental and psychiatric problem diagnosed by a physician - Having a serious neurological and orthopedic problem diagnosed by a physician - Having serious hearing and vision problems - Having uncontrolled diabetes and hypertension - Using a walking device other than a cane (crutches, walkers, etc.) - Drug use that increases the risk of falling (to be determined by the information obtained from nurses and physiotherapists working in nursing homes)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
virtual reality
The BeCure Balance Assessment System protocol used in this study; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the center of gravity of the body with images during standing and balancing for 15 seconds on the board with eyes open. In order to support the balanced development of the participants with the Becure system; Balance surfing, balance adventure, balance bowling and traffic games were played. uBall, gates, smartclean and SmartBubblePop games with Kinect for the upper extremity; KneeUp game was played on the lower extremity.

Locations

Country Name City State
Turkey Kizilay Zeynep Nedim Oyvar Nursing Home and Elderly Care Center Kartal

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tampa Kinesiophobia Scale (TKS) It measures fear of movement and fear of re-injury. It was used to evaluate the development of fear of movement after treatment. A 4-point Likert scoring (1= I strongly disagree, 4= I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates that kinesiophobia is also high. 8 weeks
Primary BeCure Balance Evaluation System The BeCure Balance Assessment System protocol used in this study; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the body center of gravity during standing balance on the board for 15 seconds with eyes open, with images. 8 weeks
Secondary Geriatric Depression Scale- Short Form It consists of 15 questions questioning the mood in the last week. This short form consists of 15 questions questioning the mood of the patient. The answers are given according to the feelings in the last week; The answers are "yes" or "no", just like in the long form, and 1 point is given for "yes" or "no" answers depending on the question. A score of 0-4 indicates no depression, 5-8 indicates mild depression, 9-11 indicates moderate depression, and a score of 12-15 indicates severe depression. 8 weeks
Secondary Mini Mental State Test Cognitive testing of the elderly, especially the elderly with delirium and/or dementia.A minimum of 0 and a maximum of 30 points can be obtained from this test. It is thought that the higher the score, the worse the mental state of the individual. 8 weeks
Secondary 5 Times Sit Up Test It is a test used to evaluate the functional strength, balance and fall risk of the lower extremities. 8 weeks
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