- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05201768
Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation
November 29, 2024 updated by: Oguzhan Dogancı, Kırıkkale University
THE OBJECTIVE OF THE RESEARCHERS IS TO DETERMINE WALKING, BALANCE, FALL RISK AND KINESIOPHOBIA IN INDIVIDUALS WITH ALZHEIMER'S DEMENTATION.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The gait, balance, fall risks and kinesiophobia of individuals with Alzheimer's Dementia will be evaluated and compared with healthy individuals.
Study Type
Observational
Enrollment (Actual)
41
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kırıkkale, Turkey
- Kırıkkale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
36 individual
Description
Inclusion Criteria:
- INDEPENDENT walker diagnosed with Alzheimer's Dementia
Exclusion Criteria:
- Having a disability to do physical activity Those who have had an operation in the last 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
INDIVIDUALS WITH ALZHEIMER
balance and gait will be evaluated survey questions will be asked
|
Individuals will be tested and recorded.
|
|
HEALTHY INDIVIDUALS
balance and gait will be evaluated survey questions will be asked
|
Individuals will be tested and recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: 5 month
|
between the ages of 50 and 80
|
5 month
|
|
Body Mass Index
Time Frame: 5 month
|
BMI was recorded in kg/m^2
|
5 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Tinetti Gait and Balance Test (TGBT)
Time Frame: 5 month
|
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.
|
5 month
|
|
Mini Mental State Test
Time Frame: 5 month
|
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.
|
5 month
|
|
Tampa Scale
Time Frame: 5 month
|
17 questions is a scale.
The scale is used in work-related activities, injury/re-injury and fear-avoidance contains the parameters.
|
5 month
|
|
The Time Up Go Test
Time Frame: 5 month
|
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.
|
5 month
|
|
The Gait Speed Measurement Test (GSMT)
Time Frame: 5 month
|
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.
|
5 month
|
|
Fall Risk Self-Assessment Scale
Time Frame: 5 month
|
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.
|
5 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Oğuzhan Doğancı, Kırıkkale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
November 1, 2022
Study Registration Dates
First Submitted
December 7, 2021
First Submitted That Met QC Criteria
January 9, 2022
First Posted (Actual)
January 21, 2022
Study Record Updates
Last Update Posted (Actual)
December 3, 2024
Last Update Submitted That Met QC Criteria
November 29, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kku-oguzhandoganci1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
test results of individuals, information such as height and weight will be published.
IPD Sharing Time Frame
1.03.2022-1.07.2022
IPD Sharing Access Criteria
open access
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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