Alzheimer DementiaNCT05767580
Comparison of Dual Assignment, Cadence, and Gait Speed in Alzheimer's Dementia and Healthy Geriatric Individuals
An observational study of Alzheimer Dementia, run by Kırıkkale University.
Trial summary
Tests will be performed in individuals with Alzheimer's dementia to compare dual-task and gait with healthy geriatric individuals. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Dementia
- What is being tested?
- evaluation
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 21 Feb 2024
- 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 65 years and older
- All sexes
- Older adult
Study population: a total of 50 individuals, including 25 geraitric individuals with Alzheimer's dementia over the age of 65 and 25 healthy geraitric individuals
Who may be able to join
- 65 years and older,
- Who volunteered to participate in the research,
- Able to walk independently,
- He was diagnosed with Alzheimer's by a physician for the experimental group,
- Having not been diagnosed with Alzheimer's for the control group
- Individuals who have not undergone surgery in the last 6 months
- Individuals who do not have cooperation and communication problems.
Who cannot join
- Under age 65
- Individuals who do not agree to participate in the research,
- Individuals who have a disability to do physical activity,
- Individuals who have undergone an operation in the last 6 months,
- Individuals with problems of cooperation and communication
About this study
Tests will be performed in individuals with Alzheimer's dementia to compare dual-task and gait with healthy geriatric individuals.
Read the detailed description
In this study, it was aimed to compare double assignment, cadence and walking speed in Alzheimer's Dementia and Healthy Geriatric Individuals.
Individuals who can walk independently and who are diagnosed with Alzheimer's Dementia over the age of 65 and healthy individuals will be included in the study. It will be done with 50 people who voluntarily participated in the research.
As a data collection tool; The demographics formula with patient descriptive features is the Timed Get Up and Walk test to turn off double assignment, the 2 Minute Walk Test to evaluate the advertisement, and the Footprint Method to use cadence. It will be assessed with the Mini Mental State Test and the Montreal Cognitive Assessment Test to examine discriminative units.
- Conditions
- Alzheimer Dementia
- Being tested
- evaluation
- Keywords
- dual task, cadance, gait speed, alzheimer demantia
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluationOther
The Timed Get Up and Go test to assess dual-tasking, the 4m Walk Test to assess gait, and the Footprint Method to assess cadence
| Study group | Role | What they receive |
|---|---|---|
| alzehimer demantia geriatric | It is a group of individuals over the age of 65, diagnosed with Alzheimer's dementia, able to walk independently, have no communication problems, and volunteer to participate in the research. Receives: Other: evaluation | |
| healty geriatric | This is a group of healthy geriatric individuals over the age of 65 who have not been diagnosed with Alzheimer's dementia, can walk independently, have no communication problems, and volunteered to participate in the study. Receives: Other: evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Up Go
Timed Start and Continue Test, In the TUG test, individuals stand up from the chair, walk 3 m, walk and sit on a swivel chair. The starting position is standardized with patients feet flat on the floor and their arms resting on the chair. The person is instructed to complete the test at their own pace and as quickly as possible. The test is started with the 'start' command. It ends with him sitting back in the chair. The test is done three times. A 2-minute rest break is given between each trial. The clinician records performance with a stopwatch for each trial.
Measured: 6 month
Secondary outcomes (3)
Dual tasking
Dual tasking (DT) is an experimental neuro-physiological process that requires an individual to perform two tasks simultaneously. When the two activities are done together, the deterioration in the performance of the tasks is defined as Dual Task Deficiency. The formula "DTD = [DT - ST]/TG × 100" was used to calculate the changes in task performances and to determine the deficiency rate, and the results were interpreted proportionally.
Measured: 6 month
Footprint method
The footprint method is carried out by pouring powder in an area of 10 m. Evaluations are made in the middle area of 6 m. The subjects started walking with the left foot and the distances of the sixth, seventh and eighth steps were measured in meters.
Measured: 6 month
Two-Minute Walk Test
Two-Minute Walk Test: It is a test used to evaluate the treatment response in moderately severe heart or lung disease or to evaluate the functional capacity of the person, which is a determinant of mortality and morbidity with a one-time measurement. Reliability, validity and responsiveness of the 2-minute walk test Amy SY Leung , Kam Keung Chan , Kevin Sykes, KS Chan demonstrated in 2006 that the 2MWT is a reliable and valid test for the assessment of exercise capacity and post-rehabilitation response in patients with moderate-to-severe COPD.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion21 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senanur AK, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767580
- Sponsor's protocol ID
- KırıkkaleUniversity-FTR-SA-71
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dual Assignment, Cadence, and Gait Speed in Alzheimer's Dementia and Healthy Geriatric Individuals
- ClinicalTrials.gov ID
- NCT05767580
- Acronym / sponsor ID
- KırıkkaleUniversity-FTR-SA-71
- Conditions
- Alzheimer Dementia
- Keywords
- dual task, cadance, gait speed, alzheimer demantia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 21 Feb 2024 (estimated)
- First posted
- 14 Mar 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.
Tests will be performed in individuals with Alzheimer's dementia to compare dual-task and gait with healthy geriatric individuals.
Detailed description
In this study, it was aimed to compare double assignment, cadence and walking speed in Alzheimer's Dementia and Healthy Geriatric Individuals.
Individuals who can walk independently and who are diagnosed with Alzheimer's Dementia over the age of 65 and healthy individuals will be included in the study. It will be done with 50 people who voluntarily participated in the research.
As a data collection tool; The demographics formula with patient descriptive features is the Timed Get Up and Walk test to turn off double assignment, the 2 Minute Walk Test to evaluate the advertisement, and the Footprint Method to use cadence. It will be assessed with the Mini Mental State Test and the Montreal Cognitive Assessment Test to examine discriminative units.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alzehimer demantia geriatric | – | Other: evaluationIt is a group of individuals over the age of 65, diagnosed with Alzheimer's dementia, able to walk independently, have no communication problems, and volunteer to participate in the research. |
| healty geriatric | – | Other: evaluationThis is a group of healthy geriatric individuals over the age of 65 who have not been diagnosed with Alzheimer's dementia, can walk independently, have no communication problems, and volunteered to participate in the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- a total of 50 individuals, including 25 geraitric individuals with Alzheimer's dementia over the age of 65 and 25 healthy geraitric individuals
Key inclusion criteria (7 listed)
- 65 years and older,
- Who volunteered to participate in the research,
- Able to walk independently,
- He was diagnosed with Alzheimer's by a physician for the experimental group,
- Having not been diagnosed with Alzheimer's for the control group
Key exclusion criteria (5 listed)
- Under age 65
- Individuals who do not agree to participate in the research,
- Individuals who have a disability to do physical activity,
- Individuals who have undergone an operation in the last 6 months,
- Individuals with problems of cooperation and communication
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 |
|---|---|---|
| evaluationThe Timed Get Up and Go test to assess dual-tasking, the 4m Walk Test to assess gait, and the Footprint Method to assess cadence | Other | alzehimer demantia geriatric, healty geriatric |
Primary outcome
Time Up Go
Time frame: 6 month
Timed Start and Continue Test, In the TUG test, individuals stand up from the chair, walk 3 m, walk and sit on a swivel chair. The starting position is standardized with patients feet flat on the floor and their arms resting on the chair. The person is instructed to complete the test at their own pace and as quickly as possible. The test is started with the 'start' command. It ends with him sitting back in the chair. The test is done three times. A 2-minute rest break is given between each trial. The clinician records performance with a stopwatch for each trial.
3 secondary outcomes
Dual tasking
Time frame: 6 month
Footprint method
Time frame: 6 month
Two-Minute Walk Test
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Dementia, run by Kırıkkale University.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Time Up Go (time frame: 6 month). 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 14 Mar 2023.