Early Diagnosis of Patients With Mild Cognitive Impairment Through the Parameterization of Functional Tests.
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Standard Care or Usual Clinical Practice
Sponsored by
About this trial
This is an interventional diagnostic trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Diagnosis, Functional tests, Kinematics, Validation, Reliability
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.
Sites / Locations
- Health Science School , University of Malaga
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mild Cognitive Impairment patients
Healthy Subjects/ Match control
Arm Description
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.
Healthy subjects of the same age as people with mild cognitive impairment.
Outcomes
Primary Outcome Measures
Kinematic analysis by motion sensor
An Inertial Sensor will pick up positioning, motion and acceleration information from the subject
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.
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.
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.
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.
Secondary Outcome Measures
Mini-Mental State Examination (MMSE)
Questionnaire 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.
Geriatric Depression Screening Scale (GDSS)
A 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 Index
It 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 Scale
It 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 function
The heart rate will be assessed using the Polar wrist heart rate monitor
Metabolic parameters
The blood lactate produced will be analysed using the Lactate Pro 2 blood lactate analyzer
Sonographic parameters
The 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.
Full Information
NCT ID
NCT03851198
First Posted
February 21, 2019
Last Updated
September 28, 2020
Sponsor
University of Malaga
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT03851198
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
Collaborators
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Diagnosis, Functional tests, Kinematics, Validation, Reliability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mild Cognitive Impairment patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Subjects/ Match control
Arm Type
Active Comparator
Arm Description
Healthy subjects of the same age as people with mild cognitive impairment.
Intervention Type
Procedure
Intervention Name(s)
Standard Care or Usual Clinical Practice
Intervention Description
The guidelines for the management according to the mild cognitive impairment in primary care will be the treatment guidelines for the Standard Care.
Primary Outcome Measure Information:
Title
Kinematic analysis by motion sensor
Description
An Inertial Sensor will pick up positioning, motion and acceleration information from the subject
Time Frame
1 hour
Title
Kinematic analysis by 3D motion capture
Description
The camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.
Time Frame
1 hour
Title
Responsiveness
Description
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.
Time Frame
1 hour
Title
Reliability
Description
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.
Time Frame
1 hour
Title
Validity
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Mini-Mental State Examination (MMSE)
Description
Questionnaire 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.
Time Frame
15 min
Title
Geriatric Depression Screening Scale (GDSS)
Description
A 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.
Time Frame
15 min
Title
Katz Index
Description
It 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.
Time Frame
15 min
Title
Lawnton & Brody Scale
Description
It 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.
Time Frame
15 min
Title
Cardiopulmonary function
Description
The heart rate will be assessed using the Polar wrist heart rate monitor
Time Frame
1 hour
Title
Metabolic parameters
Description
The blood lactate produced will be analysed using the Lactate Pro 2 blood lactate analyzer
Time Frame
1 hour
Title
Sonographic parameters
Description
The 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.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Health Science School , University of Malaga
City
Malaga
ZIP/Postal Code
29009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All the anonymised data that conform the results that will be analysed in the present clinical trial, after the de-identification, will be published in a peer review journal (tables, figures, appendices, text). Moreover, data will be available to researchers who provide a methodologically sound proposal, but data will be not publicly available. Proposals will be directed by acuesta@uma.es. To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Time Frame
Beginning 9 months following article publication in a peer review jorunal. No definite end date.
IPD Sharing 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.
Learn more about this trial
Early Diagnosis of Patients With Mild Cognitive Impairment Through the Parameterization of Functional Tests.
We'll reach out to this number within 24 hrs