Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483438
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-07
Brief Title:
Handwriting as an Objective Tool to Support the Identification of People With Alzheimers Disease
Sponsor:
University of Évora
Organization:
University of Évora
Study Overview
Official Title:
Handwriting as an Objective Tool to Support the Identification of People With Alzheimers Disease Suitability of an Assessment Protocol
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAD
Brief Summary:
Alzheimers disease AD is the most common of dementia and has associated cognitive and motor disorders with consequences on daily activities including handwriting
Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations Changes in this skill are present at different stages of the clinical course of Alzheimers Disease The sensorimotor deterioration is observed in handwriting tasks motion kinematics such as movement time speed and profiles and brain activity rhythms
Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations and changes in this skill are present at different stages of the clinical course of dementia From a theoretical perspective because sensorimotor deterioration observed in handwriting tasks motion kinematics such as movement time speed and profiles
Due to the large number of brain areas related to handwriting performance brain electrical activity analysis can be an early indicator of brain dysfunction Although there is a lack of validation across healthy and non-healthy populations Electroencephalogram EEG measures have the potential for evaluating cognitive performance
This research aims to analyze the suitability of the handwriting assessment protocol which can contribute to a more in-depth knowledge of this subject and potentially support early identification and treatment
Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations Changes in this skill are present at different stages of the clinical course of Alzheimers Disease The sensorimotor deterioration is observed in handwriting tasks motion kinematics such as movement time speed and profiles and brain activity rhythms
Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations and changes in this skill are present at different stages of the clinical course of dementia From a theoretical perspective because sensorimotor deterioration observed in handwriting tasks motion kinematics such as movement time speed and profiles
Due to the large number of brain areas related to handwriting performance brain electrical activity analysis can be an early indicator of brain dysfunction Although there is a lack of validation across healthy and non-healthy populations Electroencephalogram EEG measures have the potential for evaluating cognitive performance
This research aims to analyze the suitability of the handwriting assessment protocol which can contribute to a more in-depth knowledge of this subject and potentially support early identification and treatment
Detailed Description:
The minimum sample size for this pilot study is 75 participants which is the minimum sample size calculated by Gpower 90 power significance level 005 to perform the planned between-group comparisons ANOVA correlations Pearson and nonlinear analyses Participants who agree to participate in this study will be asked to provide demographic information such as age Portuguese as a native language education level motorphysical problems and medical problems By underlining the social relevance of the project the investigators anticipate that at least 80 of the invited subjects will be interested in participating in this research
In the first phase the request for analysis of this project by the Ethics Committee and the Scientific Council of the University of Évora was made After approval the entities were contacted to present the project and start contact with the participants Then each participant or their legal tutor gave informed consent where they were aware of the confidentiality of the data collected throughout the study and that they would not be disclosed being only used for academic purposes
Subjects were invited to participate in three organizations Espírito Santo Hospital of Évora HESE and two Residential Centers for the Elderly Two types of participants were recruited in these organizations At HESE participants with a diagnosis of dementia validated by the medical team of the Neurology Service and some of their healthy family members without a diagnosis At the Residential Centre for the Elderly participants who did not have any medical diagnosis record were subject to a neuropsychological evaluation lasting approximately 60 minutes to differentiate the group of participants with and without dementia and not to define which type of dementia All participants will take a handwriting assessment lasting approximately 60 minutes
The data will be analyzed using the Statistical Package for the Social Sciences SPSS to conduct a cross-sectional study
For the neuropsychological assessment the following instruments will be used
Semi-structured interview of neuropsychological anamnesis This interview was conducted directly with the individual and will be divided into nine topics i personal data ii reason for the request iii clinical history iv school and professional background v complaints vi impact of brain injury vii other information viii the rationale of the neuropsychological assessment and ix inventory on the anamnesis as the first occasion of evaluation via direct observation method
The Geriatric Depression Scale GDS is a scale specifically developed for use in the elderly population which combines administration and an easy-to-use response format It consists of 30 items that have two possible answers Yes No with two domains cognitive and affective The total result varies between 0 and 30 points 0-10 points absence of depressive symptoms11-20 points mild depressive symptoms or 21-30 points severe depressive symptoms
-The Mini-Mental State Examination MMSE is one of the most widely used instruments in screening cognitive deficits The cut-off points are 22 for literacy from 0 to 2 years 24 for literacy from 3 to 6 years and 27 for literacy equal to or greater than 7 years
The Mattis Dementia Rating Scale DRS-2 is a validated neuropsychological battery for assessing cognition in general including attention initiativeperseverance visuospatial construction conceptualization and memory The cut-off point used is the tenth percentile of normative data for the Portuguese population of age and educational level
Clock Design Test is a neuropsychological test often used in dementia screening
The handwriting assessment will be carried out by a psychomotor therapist with extensive experience The instruments will be
Beery Buktenica Visual-Motor Integration Development Test - 6 VMI-6 to be the visual-motor integration the Portuguese translation and adaptation of the This instrument are composed of three distinct tests - Visuomotor Integration Development Test Visual Perception Development Test and Motor Coordination Development Test - evaluates visual-motor integration visuo-perceptual skills and motor coordination respectively
Adult Writing Assessment Battery HAB To assess pen control writing speed and readability in adults a This battery of tests includes different subtests to assess motor and writing skills used in everyday life Each sub-test is assessed by a specific algorithm which determines the percentage of letters and numbers that the participant can write legibly The final evaluation is carried out on a quotation sheet The HAB will be carried out on a Wacom digitizing platform and the data extraction will be done through the MovAlyzeR software
NeuroScript MovAlyzeR software version 61 will be used to analyze the performance of older adults on VMI in relation to spatial temporal and kinematic variables of writing
EPOC X is a noninvasive wireless electrophysiology procedure that will be used to assess brain activity during the handwriting task through the HAB
The Movsense application enables the use of portable sensors which can be affixed to the individuals skin or clothing and collect various biomechanical data associated with arm movement
The data will be collected individually directly with the individual in the classroom using a table and a chair to perform the tasks in two sessions one for neuropsychological assessment and the other for motor assessment This data collection will take place after the completion of the Informed Consent
Stroke verticalhorizontal start position verticalhorizontal size slant reaction time duration and pen pressure will be aggregated to obtain the handwriting cinematics
The brain activity will be measured by the calculation of the spectral density mean from theta alpha-1and beta bands
Handwriting legibility will be given by the total score from HAB and the visuomotor will be reported by total and partial score from the VMI-6
In the first phase the request for analysis of this project by the Ethics Committee and the Scientific Council of the University of Évora was made After approval the entities were contacted to present the project and start contact with the participants Then each participant or their legal tutor gave informed consent where they were aware of the confidentiality of the data collected throughout the study and that they would not be disclosed being only used for academic purposes
Subjects were invited to participate in three organizations Espírito Santo Hospital of Évora HESE and two Residential Centers for the Elderly Two types of participants were recruited in these organizations At HESE participants with a diagnosis of dementia validated by the medical team of the Neurology Service and some of their healthy family members without a diagnosis At the Residential Centre for the Elderly participants who did not have any medical diagnosis record were subject to a neuropsychological evaluation lasting approximately 60 minutes to differentiate the group of participants with and without dementia and not to define which type of dementia All participants will take a handwriting assessment lasting approximately 60 minutes
The data will be analyzed using the Statistical Package for the Social Sciences SPSS to conduct a cross-sectional study
For the neuropsychological assessment the following instruments will be used
Semi-structured interview of neuropsychological anamnesis This interview was conducted directly with the individual and will be divided into nine topics i personal data ii reason for the request iii clinical history iv school and professional background v complaints vi impact of brain injury vii other information viii the rationale of the neuropsychological assessment and ix inventory on the anamnesis as the first occasion of evaluation via direct observation method
The Geriatric Depression Scale GDS is a scale specifically developed for use in the elderly population which combines administration and an easy-to-use response format It consists of 30 items that have two possible answers Yes No with two domains cognitive and affective The total result varies between 0 and 30 points 0-10 points absence of depressive symptoms11-20 points mild depressive symptoms or 21-30 points severe depressive symptoms
-The Mini-Mental State Examination MMSE is one of the most widely used instruments in screening cognitive deficits The cut-off points are 22 for literacy from 0 to 2 years 24 for literacy from 3 to 6 years and 27 for literacy equal to or greater than 7 years
The Mattis Dementia Rating Scale DRS-2 is a validated neuropsychological battery for assessing cognition in general including attention initiativeperseverance visuospatial construction conceptualization and memory The cut-off point used is the tenth percentile of normative data for the Portuguese population of age and educational level
Clock Design Test is a neuropsychological test often used in dementia screening
The handwriting assessment will be carried out by a psychomotor therapist with extensive experience The instruments will be
Beery Buktenica Visual-Motor Integration Development Test - 6 VMI-6 to be the visual-motor integration the Portuguese translation and adaptation of the This instrument are composed of three distinct tests - Visuomotor Integration Development Test Visual Perception Development Test and Motor Coordination Development Test - evaluates visual-motor integration visuo-perceptual skills and motor coordination respectively
Adult Writing Assessment Battery HAB To assess pen control writing speed and readability in adults a This battery of tests includes different subtests to assess motor and writing skills used in everyday life Each sub-test is assessed by a specific algorithm which determines the percentage of letters and numbers that the participant can write legibly The final evaluation is carried out on a quotation sheet The HAB will be carried out on a Wacom digitizing platform and the data extraction will be done through the MovAlyzeR software
NeuroScript MovAlyzeR software version 61 will be used to analyze the performance of older adults on VMI in relation to spatial temporal and kinematic variables of writing
EPOC X is a noninvasive wireless electrophysiology procedure that will be used to assess brain activity during the handwriting task through the HAB
The Movsense application enables the use of portable sensors which can be affixed to the individuals skin or clothing and collect various biomechanical data associated with arm movement
The data will be collected individually directly with the individual in the classroom using a table and a chair to perform the tasks in two sessions one for neuropsychological assessment and the other for motor assessment This data collection will take place after the completion of the Informed Consent
Stroke verticalhorizontal start position verticalhorizontal size slant reaction time duration and pen pressure will be aggregated to obtain the handwriting cinematics
The brain activity will be measured by the calculation of the spectral density mean from theta alpha-1and beta bands
Handwriting legibility will be given by the total score from HAB and the visuomotor will be reported by total and partial score from the VMI-6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None