Clinical trial NCT03851198: Early Diagnosis of Patients With Mild Cognitive Impairment Through the Parameterization of Functional Tests.
Official title: Early Diagnosis of Patients With Mild Cognitive Impairment Through the Parameterization of Functional Tests.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Diagnosis
Functional tests
Kinematics
Validation
Reliability
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2019-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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.

Primary outcomes:
measure: Kinematic analysis by motion sensor
timeFrame: 1 hour
measure: Kinematic analysis by 3D motion capture
timeFrame: 1 hour
measure: Responsiveness
timeFrame: 1 hour
measure: Reliability
timeFrame: 1 hour
measure: Validity
timeFrame: 1 hour
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: 15 min
measure: Geriatric Depression Screening Scale (GDSS)
timeFrame: 15 min
measure: Katz Index
timeFrame: 15 min
measure: Lawnton & Brody Scale
timeFrame: 15 min
measure: Cardiopulmonary function
timeFrame: 1 hour
measure: Metabolic parameters
timeFrame: 1 hour
measure: Sonographic parameters
timeFrame: 1 hour
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Health Science School , University of Malaga
Study officials:
References: