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

NCT03851198 | Withdrawn

• 1 other identifier: IJFA07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Diagnosis; Functional tests; Kinematics; Validation; Reliability

Outcome Measures

Primary Outcomes (5)

• Kinematic analysis by motion sensor

  An Inertial Sensor will pick up positioning, motion and acceleration information from the subject

  1 hour

• Kinematic analysis by 3D motion capture

  The camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.

  1 hour

• Responsiveness

  The Responsiveness Box of COSMIN checklist will be used to determinate the response to change of the Inertial Sensor and the 3D cameras. All possible items will be followed.

  1 hour

• Reliability

  The Reliability Box of COSMIN checklist will be used to determinate the Test-Retest reliability of the Inertial Sensor and the 3D cameras. All possible items will be followed.

  1 hour

• Validity

  The Criterion Validity Box of COSMIN checklist will be used to determinate the correlation between data from the Inertial Sensor and the 3D camera. All possible items will be followed.

  1 hour

Secondary Outcomes (7)

• Mini-Mental State Examination (MMSE)

  15 min

• Geriatric Depression Screening Scale (GDSS)

  15 min

• Katz Index

  15 min

• Lawnton & Brody Scale

  15 min

• Cardiopulmonary function

  1 hour

Study Arms (2)

Mild Cognitive Impairment patients

EXPERIMENTAL

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.

Procedure: Standard Care or Usual Clinical Practice

Healthy Subjects/ Match control

ACTIVE COMPARATOR

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

Procedure: Standard Care or Usual Clinical Practice

Interventions

Standard Care or Usual Clinical Practice 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; Mild Cognitive Impairment patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• King's College London: collaborator

Study Sites (1)

Health Science School , University of Malaga

Málaga, 29009, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: April 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 7, 2023

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months following article publication in a peer review jorunal. No definite end date.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Proposals will be directed by acuesta@uma.es. To gain access, data requestors will need to sign a data access agreement.

Locations

ES (1)