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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03851198
Enrollment
0
Registered
2019-02-22
Start date
2020-04-01
Completion date
2021-09-01
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

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

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.

Interventions

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

Sponsors

King's College London
CollaboratorOTHER
University of Malaga
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Kinematic analysis by motion sensor1 hourAn Inertial Sensor will pick up positioning, motion and acceleration information from the subject
Kinematic analysis by 3D motion capture1 hourThe camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.
Responsiveness1 hourThe 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.
Reliability1 hourThe 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.
Validity1 hourThe 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

MeasureTime frameDescription
Metabolic parameters1 hourThe blood lactate produced will be analysed using the Lactate Pro 2 blood lactate analyzer
Mini-Mental State Examination (MMSE)15 minQuestionnaire used for the cognitive state assessment. The Mini-Mental State Examination includes eleven questions. The maximum total score is 30 points. It is divided into two sections, the first of which requires only vocal responses and covers orientation, memory and attention; the maximum score is 21. The second part assess the ability to name, follow verbal and written commands, write a sentence spontaneously and copy a complex polygon similar to a Bender-Gestalt figure; the maximum score is 9. As usual, a score lower 24 points points is indicatives of dementia.
Sonographic parameters1 hourThe thickness of the subcutaneous fat and the anterior rectus quadriceps muscle, and the eco-intensity of the subcutaneous fat and the anterior rectus quadriceps muscle, both at rest and in maximum voluntary isometric contraction, will be collected.
Geriatric Depression Screening Scale (GDSS)15 minA questionnaire designed to detect depression in older adults. This scale consists of 30 items (answer format yes / no). Less score is indicative of depression. Generally, a score below 15 points is already indicatives of depression.
Katz Index15 minIt is a hetero-administered questionnaire used to assess activities of daily living that includes 6 dichotomous items (bathing, dressing, goimt to toilet, transfer, continence, feeding). It is scored considering the items individually, so that 0 points are given when the activity is performed independently and 1 point if the activity is done with help or not done. The score varies from 0 to 6 points, with a higher score indicative of greater dependence on the development of activities of daily living.
Lawnton & Brody Scale15 minIt is a hetero-administered questionnaire used to assess instrumented activities of daily living that includes the assessment of 8 activities of daily living (ability to use the telephone, shopping, food preparation, housekeeping, laundry, mode of transporation, responsibility for own medications and ability to handle finances). The score varies from 0 to 8 points. 0 points are given when the activity is performed independently and 1 point if the activity is done with help or not done. There is no cut-off point, but a higher score is indicative of worse performance of instrumental activities or less functionality.
Cardiopulmonary function1 hourThe heart rate will be assessed using the Polar wrist heart rate monitor

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026