Comparison of Dual Assignment, Cadence, and Gait Speed in Alzheimer's Dementia and Healthy Geriatric Individuals

March 2, 2023 updated by: Senanur AK, Kırıkkale University
Tests will be performed in individuals with Alzheimer's dementia to compare dual-task and gait with healthy geriatric individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: evaluation
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
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.
Other: evaluation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dual tasking
Time Frame: 6 month
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.
6 month
Footprint method
Time Frame: 6 month
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.
6 month
Two-Minute Walk Test
Time Frame: 6 month
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KırıkkaleUniversity-FTR-SA-71

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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