Early Diagnosis of Patients With Mild Cognitive Impairment Through the Parameterization of Functional Tests.

NCT ID: NCT03851198

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-09-01

Brief Summary

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The present study aims to develop an index formed by the variables, functional tests, scales and instruments that best discriminate between healthy subjects and subjects with MCI and that allows the stratification of different levels of severity of MCI, and to validate new systems for the early diagnosis of subjects with mild cognitive impairment.

Detailed Description

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Dementia affects 46.8 million people and in 2050 it is expected that there will be between 115-135 million people suffering from dementia. Inside dementias, Mild Cognitive Impairment (MCI) has a prevalence in adults aged ≥65 years of 10-20%.

Patients with MCI also show greater progression towards dementia, higher mortality and disability, and a greater use of medical care compared to cognitively normal subjects that converts MCI into an important public health problem, which reinforces the need to perfect clinic assessment procedures to improve the early identification of individuals with MCI. Early diagnosis could allow effective medical treatments that prevent or slow the onset of dementia, and could improve the effectiveness of non-pharmacological interventions.

Currently, it can be used an Inertial Sensor and 3D motion capture systems with a camera to analyse kinematics and these instruments are being integrated as a rehabilitation tool in patients. The use of Inertial Sensor and 3D motion capture cameras would help to find fast and cheap assessment methods for professionals.

Conditions

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Mild Cognitive Impairment

Keywords

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Mild Cognitive Impairment Diagnosis Functional tests Kinematics Validation Reliability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mild Cognitive Impairment patients

Subjects diagnosed with mild cognitive impairment, who will receive the best treatment of clinical practice, will be recruited. They must be more than 60 years old.

Group Type EXPERIMENTAL

Standard Care or Usual Clinical Practice

Intervention Type PROCEDURE

The guidelines for the management according to the mild cognitive impairment in primary care will be the treatment guidelines for the Standard Care.

Healthy Subjects/ Match control

Healthy subjects of the same age as people with mild cognitive impairment.

Group Type ACTIVE_COMPARATOR

Standard Care or Usual Clinical Practice

Intervention Type PROCEDURE

The guidelines for the management according to the mild cognitive impairment in primary care will be the treatment guidelines for the Standard Care.

Interventions

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Standard Care or Usual Clinical Practice

The guidelines for the management according to the mild cognitive impairment in primary care will be the treatment guidelines for the Standard Care.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects over 60 years of age.
* Healthy subjects and subjects diagnosed with mild cognitive impairment.
* Subjects able of filling out questionnaires and performing functional tests.

Exclusion Criteria

* Participants with neurological pathologies other than mild cognitive impairment.
* Participation in an experimental study where they receive a treatment.
* Score on the Mini-Mental State Examination of less than 24.
* Inability to get up from the chair at least 5 times or 30 seconds
* Inability to walk 20 meters.
* Inability to raise up both arms to 90 degrees or lifting 2 kg with the hand.
* Inability to walk independently without a walking assistance device (cane, crutch or walker).
* Patients with prescription of beta-blockers.
* Inability to provide informed consent.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Dr. Antonio I Cuesta-Vargas

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Health Science School , University of Malaga

Málaga, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IJFA07

Identifier Type: -

Identifier Source: org_study_id