GeriatricNCT05993624
The Effect of Exergame Games on Geriatric Individuals With Kinesiophobia
A study testing virtual reality in people with Geriatric and Kinesiophobia, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric, Kinesiophobia
- What is being tested?
- virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2023to 17 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kızılay Zeynep Nedim Oyvar Nursing Home and Elderly Care Center
Kartal, 34860
About this study
Official title: The Effect of Exergame Games on Kinesiophobia, Balance, Lower Extremity Muscle Strength, Depression and Cognitive Function in Geriatric Individuals With Kinesiophobia
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.
Read the detailed 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.
- Conditions
- Geriatric, Kinesiophobia
- Being tested
- virtual reality
- Keywords
- geriatrics, kinesiophobia, virtual reality, video based game, Xbox 360 KinectTM
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Group | Other | Participants in the study played 30-minute exergame games once a week for 8 weeks and rehabilitation was applied. Before starting the application, the 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 5 times the risk of falling. lifting test was performed. These tests were repeated at the end of 8 sessions and before and after values were measured. Receives: Device: virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
5 Times Sit Up Test
It is a test used to evaluate the functional strength, balance and fall risk of the lower extremities.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start17 Feb 2023
- Primary completion5 Apr 2023
- Study completion17 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Sever, Istanbul Medipol University Hospital
- Investigators
- Ebru SEVER, Lecturer, Study director, Department of Physiotherapy & Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993624
- Sponsor's protocol ID
- ELMİRAHASRET
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exergame Games on Kinesiophobia, Balance, Lower Extremity Muscle Strength, Depression and Cognitive Function in Geriatric Individuals With Kinesiophobia
- ClinicalTrials.gov ID
- NCT05993624
- Acronym / sponsor ID
- ELMİRAHASRET
- Conditions
- Geriatric, Kinesiophobia
- Keywords
- geriatrics, kinesiophobia, virtual reality, video based game, Xbox 360 KinectTM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 17 Jun 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Group | Other | Device: virtual realityParticipants in the study played 30-minute exergame games once a week for 8 weeks and rehabilitation was applied. Before starting the application, the 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 5 times the risk of falling. lifting test was performed. These tests were repeated at the end of 8 sessions and before and after values were measured. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual realityThe 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. | Device | Rehabilitation Group |
Primary outcome
Tampa Kinesiophobia Scale (TKS)
Time frame: 8 weeks
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.
BeCure Balance Evaluation System
Time frame: 8 weeks
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.
3 secondary outcomes
Geriatric Depression Scale- Short Form
Time frame: 8 weeks
Mini Mental State Test
Time frame: 8 weeks
5 Times Sit Up Test
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru SEVER, Lecturer study director
Department of Physiotherapy & Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Geriatric and Kinesiophobia, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Kinesiophobia Scale (TKS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.