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Clinical Trials/NCT03851198
NCT03851198
Withdrawn
N/A

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

University of Malaga1 site in 1 countryApril 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
University of Malaga
Locations
1
Primary Endpoint
Reliability
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
September 1, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Antonio I Cuesta-Vargas

PhD

University of Malaga

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Reliability

Time Frame: 1 hour

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.

Kinematic analysis by motion sensor

Time Frame: 1 hour

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

Kinematic analysis by 3D motion capture

Time Frame: 1 hour

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

Responsiveness

Time Frame: 1 hour

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.

Validity

Time Frame: 1 hour

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.

Secondary Outcomes

  • Mini-Mental State Examination (MMSE)(15 min)
  • Sonographic parameters(1 hour)
  • Geriatric Depression Screening Scale (GDSS)(15 min)
  • Katz Index(15 min)
  • Lawnton & Brody Scale(15 min)
  • Metabolic parameters(1 hour)
  • Cardiopulmonary function(1 hour)

Study Sites (1)

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