Alzheimer DiseaseNCT05201768
Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation
An observational study of Alzheimer Disease, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
THE OBJECTIVE OF THE RESEARCHERS IS TO DETERMINE WALKING, BALANCE, FALL RISK AND KINESIOPHOBIA IN INDIVIDUALS WITH ALZHEIMER'S DEMENTATION. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- balance tests,questionnaire
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Nov 2022
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 36 individual
Who may be able to join
- INDEPENDENT walker diagnosed with Alzheimer's Dementia
Who cannot join
- Having a disability to do physical activity Those who have had an operation in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
THE OBJECTIVE OF THE RESEARCHERS IS TO DETERMINE WALKING, BALANCE, FALL RISK AND KINESIOPHOBIA IN INDIVIDUALS WITH ALZHEIMER'S DEMENTATION.
Read the detailed description
The gait, balance, fall risks and kinesiophobia of individuals with Alzheimer's Dementia will be evaluated and compared with healthy individuals.
- Conditions
- Alzheimer Disease
- Being tested
- balance tests,questionnaire
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance tests,questionnaireOther
Individuals will be tested and recorded.
| Study group | Role | What they receive |
|---|---|---|
| INDIVIDUALS WITH ALZHEIMER | balance and gait will be evaluated survey questions will be asked Receives: Other: balance tests,questionnaire | |
| HEALTHY INDIVIDUALS | balance and gait will be evaluated survey questions will be asked Receives: Other: balance tests,questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
between the ages of 50 and 80
Measured: 5 month
Body Mass Index
BMI was recorded in kg/m^2
Measured: 5 month
Secondary outcomes (6)
The Tinetti Gait and Balance Test (TGBT)
TGBT consists of balance and gait subheadings. For balance, there are 13 items, and 9 items for gait. Items are scored as 0 (abnormal), 1 (adaptive) and 2 (normal) for balance, 0 (abnormal), 1 (normal) for gait. The maximum balance score of the patient is 26 and the maximum gait score is 9. Total score (balance + walking) is 35 points.
Measured: 5 month
Mini Mental State Test
It was used to determine the cognitive state before the training. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points.
Measured: 5 month
Tampa Scale
17 questions is a scale. The scale is used in work-related activities, injury/re-injury and fear-avoidance contains the parameters.
Measured: 5 month
The Time Up Go Test
The timed "Up \& Go" measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm), walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
Measured: 5 month
The Gait Speed Measurement Test (GSMT)
For GSMT, individuals were asked to walk at a speed they wanted on a flat surface of 14 m. Signs were placed on the 2nd and 12th meters of the test area to minimize the speed changes between walking start and walking finish, and to make a more objective measurement. The walking time at this 10-meter distance was measured with the stopwatch and the results were recorded in sec and the walking speed was determined.
Measured: 5 month
Fall Risk Self-Assessment Scale
It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who get 4 points or more from the scoring are classified as having a high risk of falling.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguzhan Dogancı, Kırıkkale University
- Investigators
- Oğuzhan Doğancı, Study chair, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201768
- Sponsor's protocol ID
- kku-oguzhandoganci1
- Status last verified
- Nov 2024
- First submitted
- 7 Dec 2021
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: test results of individuals, information such as height and weight will be published.
Publications
Doganci O, Sertel M. Determination of balance, fall risk, and kinesiophobia in individuals with Alzheimer's Dementia. Front Psychol. 2025 Mar 11;16:1535440. doi: 10.3389/fpsyg.2025.1535440. eCollection 2025.
PubMed 40134734
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation
- ClinicalTrials.gov ID
- NCT05201768
- Acronym / sponsor ID
- kku-oguzhandoganci1
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 21 Jan 2022 (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 OBJECTIVE OF THE RESEARCHERS IS TO DETERMINE WALKING, BALANCE, FALL RISK AND KINESIOPHOBIA IN INDIVIDUALS WITH ALZHEIMER'S DEMENTATION.
Detailed description
The gait, balance, fall risks and kinesiophobia of individuals with Alzheimer's Dementia will be evaluated and compared with healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INDIVIDUALS WITH ALZHEIMER | – | Other: balance tests,questionnairebalance and gait will be evaluated survey questions will be asked |
| HEALTHY INDIVIDUALS | – | Other: balance tests,questionnairebalance and gait will be evaluated survey questions will be asked |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 36 individual
Key inclusion criteria (1 listed)
- INDEPENDENT walker diagnosed with Alzheimer's Dementia
Key exclusion criteria (1 listed)
- Having a disability to do physical activity Those who have had an operation in the last 6 months
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 |
|---|---|---|
| balance tests,questionnaireIndividuals will be tested and recorded. | Other | HEALTHY INDIVIDUALS, INDIVIDUALS WITH ALZHEIMER |
Primary outcome
Age
Time frame: 5 month
between the ages of 50 and 80
Body Mass Index
Time frame: 5 month
BMI was recorded in kg/m^2
6 secondary outcomes
The Tinetti Gait and Balance Test (TGBT)
Time frame: 5 month
Mini Mental State Test
Time frame: 5 month
Tampa Scale
Time frame: 5 month
The Time Up Go Test
Time frame: 5 month
The Gait Speed Measurement Test (GSMT)
Time frame: 5 month
Fall Risk Self-Assessment Scale
Time frame: 5 month
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 3 Dec 2024.
- Derived from this study: PubMed 40134734Doganci O, Sertel M. Determination of balance, fall risk, and kinesiophobia in individuals with Alzheimer's Dementia. Front Psychol. 2025 Mar 11;16:1535440. doi: 10.3389/fpsyg.2025.1535440. eCollection 2025.
- Individual participant dataSharing planned: Yes. test results of individuals, information such as height and weight will be published.
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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.
Oğuzhan Doğancı study chair
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Kırıkkale University 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 1 inclusion and 1 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 3 Dec 2024. 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?
Age (time frame: 5 month). 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?
On the ClinicalTrials.gov record for NCT05201768, which also lists 1 linked publication.
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 3 Dec 2024.