- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06693401
Forensic Handwriting Analysis in People with Parkinson's Disease - Pilot Study
Forensic Analysis of Dynamic Handwriting Characteristics After Rehabilitation Intervention in People with Parkinson's Disease - Pilot Study
Graphoscopic analysis of handwriting is influenced by various internal and external factors, and individuals with degenerative diseases like Parkinson's face challenges due to limitations in motor abilities, impacting Instrumental Activities of Daily Living (IADL) such as handwriting skills. The absence of encouraging outcomes from interventions in handwriting rehabilitation programs and graphoscopic assessment tools, persists as an ongoing challenge.
This pilot study undertook an investigation into the forensic characterization of handwriting in people with Parkinson's Disease (PD). The main goal was to evaluate and compare the effect of 2 rehabilitation programs on handwriting, particularly, regarding 9 static and dynamic features, in individuals with PD.
Additionally, this study contributed to the development of a comprehensive protocol, incorporating the most suitable and discriminatory clinical and graphoscopic assessment tools in the context of PD, and to formulate an occupational therapy rehabilitation program focused on enhancing the dexterity and fine motor skills of the upper limbs, crucial for improved performance in Instrumental Activities of Daily Living (IADLs).
The pilot trial involved two groups: an intervention group (IG) undergoing traditional physiotherapy and occupational therapy programs (TPRP + OTRP), and a control group (CG) undergoing traditional physiotherapy alone (TPRP).
The objective was to characterize and compare handwriting before and after the rehabilitation programs.
Participants underwent assessments at the study's commencement and after 12 weeks of intervention. Graphoscopic assessment utilized a Wacom One DTC133W0A tablet and NeuroScript's v6.1 MovAlyzeR software. Clinical assessments included the Jebsen Taylor Hand Function Test, Movement Disorder Society Unified Parkinson Disease Rate Scale, and the Parkinson Disease Questionnaire 8 tests.
Study Overview
Status
Conditions
Detailed Description
The potential participants were recruited through the Clínica Neurovida and Clínica de Fisioterapia Egas Moniz (Monte da Caparica) who, on their own initiative, start attending the partner institutions or are members. People who meet the eligibility criteria, after initial clinical diagnosis, were invited to participate in this study. Before entering the clinical trial, participants were fully briefed on the conditions under which they underwent during the tests and rehabilitation program procedures, after which a consent informed form was signed for the use of these results for research purposes. The collection, processing and dissemination of data were carried out anonymously.
Both intervention programs were performed during 12 weeks.
- Traditional physiotherapy rehabilitation program (TPRP) (practice for 1h, twice a week) - implemented according to the European Physiotherapy Guideline for Parkinson's Disease.
- Occupational therapy rehabilitation program (OTRP) - implemented through workbooks, practice for 30 min, three times a week, according to the Guidelines for Occupational Therapy in Parkinson's Disease Rehabilitation.
The motor tasks for the OTRP consists in performing, 2-3 times a week, exercises included in a workbook (drawing the upper and lower case letters of the alphabet guided by dotted lines, writing a sentence with and without spatial limits) and performing 3 groups of fine motor tasks: Hand manipulation (2 exercises), Finger isolation (3 exercises), Finger flexion and extension (2 exercises) and Coordination (1 exercise). All exercises should be performed 10 times, in triplicate, for each hand. Subjects evaluate the subjective performance of the execution through a questionnaire at the end of each exercise where they indicate whether they performed fully, partially or not at all.
Handwriting Sample collection In the first stage, the participants of this pilot trial were asked to perform specific motor tasks (estimated time -15 min) by the researcher responsible for sample collection, directly on the surface of a digitizer (Wacom One 13'), using an appropriate stylus and capturing software (MovAlyzeR v6.1 - NeuroScript) (t0). These samples were adequately identified and conditioned. After assessment (t0), both groups (control and intervention) were submitted to a rehabilitation intervention, followed by handwriting assessments after 12 weeks (t1) of rehabilitation interventions. Dynamic features (e.g.: average pen pressure, normalized jerk, duration, horizontal size, vertical size, relative pen down duration, number of acceleration peaks, average absolute velocity and absolute size) were extracted and compared from the digital samples collected before (t0) and after the rehabilitation intervention (t1).
Motor function assessment Assessment of motor function were performed in the 2 evaluation moments (t0, t1): upper limb throughout MDS UPDRS (2.7, 3.3.b, 3.3c, 3.4.a, 3.4.b, 3.5.a, 3.5.b, 3.6.a, 3.6.b) and Jebsen-Taylor tests.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Monte de Caparica
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Almada, Monte de Caparica, Portugal, 2829-699
- Egas Moniz School of Health and Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- individuals with an early to middle diagnosis of PD stage 2-3 on the Hoehn and Yahr scale
- level of education from the fourth grade onwards
- Portuguese as their native language.
Exclusion Criteria:
- presence of physical or mental pathologies or clinical conditions other than PD that may impact writing or the nervous system
- color blindness
- deafness
- thyroid gland dysfunctions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Physiotherapy programme
The active comparator arm consisted of implementing the conventional physiotherapy programme in accordance to the usual physiotherapeutic rehabilitation approach through a programme tailored to the specific difficulties of each individual and adapted to their needs on a session-by-session basis and framed according the European and American Guidelines for Physical Therapy in Parkinson's Disease.
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In this group only the conventional physiotherapy programme was implemented.
This programme has the purpose of improving balance and reducing the risk of falls, enhancing mobility and motor function, managing muscle stiffness and rigidity, addressing gait abnormalities, and providing education and support.
In this regard, participants were guided and supervised in each physiotherapy session by a Parkinson's disease healthcare specialist.
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Experimental: Physiotherapy programme + Occupational Therapy programme
The experimental arm consisted of adding an occupational therapy programme to the conventional physiotherapy programme.
The occupational therapy intervention consisted in fine motor tasks exercises implemented to address hand dexterity by training hand function with a range of exercises that enhance the main skills that make our hands useful and functional, such as object manipulation, finger isolation, finger and hand extension and flexion, and coordination and handwriting exercises in Portuguese language.
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In intervention group both Physiotherapy and Occupational Therapy programmes were implemented. Occupational Therapy programme consisted in trainning the amplitude of the movements involved in the realization of each letter of the alphabet separately and through fine motor exercises. Specifically the tasks consisted of performing:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Absolute Size
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Absolute Size (pt - point, 1/72 of an inch) was assessed through Graphoscopic assessment for each exercise: drawing a narrow Archimedean spiral (SSD), drawing a wide Archimedean spiral (SLD) , drawing two overlapping regular pentagons (PTG), and writing a sentence (WRI) "Os peixes retiram o ar da água" (Fish extract air out of water).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Horizontal Size (HS)
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Horizontal Size (pt - point, 1/72 of an inch) was assessed through Graphoscopic assessment for each exercise: drawing a narrow Archimedean spiral (SSD), drawing a wide Archimedean spiral (SLD) , drawing two overlapping regular pentagons (PTG), and writing a sentence (WRI) "Os peixes retiram o ar da água" (Fish extract air out of water).Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Vertical Size
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Vertical Size (pt - point, 1/72 of an inch) was assessed through Graphoscopic assessment for each exercise: drawing a narrow Archimedean spiral (SSD), drawing a wide Archimedean spiral (SLD) , drawing two overlapping regular pentagons (PTG), and writing a sentence (WRI) "Os peixes retiram o ar da água" (Fish extract air out of water).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Average Absolute Velocity
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Average Absolute Velocity (pt/s ) was assessed through Graphoscopic assessment for each exercise: drawing a narrow Archimedean spiral (SSD), drawing a wide Archimedean spiral (SLD) , drawing two overlapping regular pentagons (PTG), and writing a sentence (WRI) "Os peixes retiram o ar da água" (Fish extract air out of water).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Duration
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Duration (s) was assessed through Graphoscopic assessment for each exercise: drawing a narrow Archimedean spiral (SSD), drawing a wide Archimedean spiral (SLD) , drawing two overlapping regular pentagons (PTG), and writing a sentence (WRI) "Os peixes retiram o ar da água" (Fish extract air out of water).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Relative Pen-Down Duration
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Relative Pen-Down Duration (s) was assessed through Graphoscopic assessment for each exercise: drawing a narrow Archimedean spiral (SSD), drawing a wide Archimedean spiral (SLD) , drawing two overlapping regular pentagons (PTG), and writing a sentence (WRI) "Os peixes retiram o ar da água" (Fish extract air out of water).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Average Pen Pressure
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Average Pen Pressure (g) was assessed through Graphoscopic assessment for each exercise: drawing a narrow Archimedean spiral (SSD), drawing a wide Archimedean spiral (SLD) , drawing two overlapping regular pentagons (PTG), and writing a sentence (WRI) "Os peixes retiram o ar da água" (Fish extract air out of water).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Normalized Jerk
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Normalized Jerk (m/s^3) was assessed through Graphoscopic assessment for each exercise: drawing a narrow Archimedean spiral (SSD), drawing a wide Archimedean spiral (SLD) , drawing two overlapping regular pentagons (PTG), and writing a sentence (WRI) "Os peixes retiram o ar da água" (Fish extract air out of water).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Parkinson Disease Questionnaire 8 (PDQ-8)
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Parkinson Disease Questionnaire 8 (score: range from 0 to 32 points) was assessed through clinical assessment and is a simplified tool derived from the PDQ-39 questionnaire, which assesses the overall well-being of an individual with Parkinson's disease (PD).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) (score: range from 0 to 26 points) was assessed through clinical assessment and is a comprehensive scale that evaluates both motor and non-motor symptoms of PD.
In this particular study, the following subgroupsof the Official MDS UPDRS Portuguese Translation were considered: Writing (item 2.7); Bradykinesia (items 3.4, 3.5 and 3.6) and Tremor (items 3.15, 3.16 and 3.17).
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Jebsen-Taylor Hand Function Test (JTHFT)
Time Frame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Jebsen-Taylor Hand Function Test (JTHFT) (s) was assessed through clinical assessment and is a tool commonly used by occupational therapists to characterize manual function in individuals with PD.
This test evaluates the time taken to complete 7 exercises with the left and right hand.
The mean reference subtest scores are considered for women and men, stratified by age groups (20-59 years and 60-94), and presented for both dominant and non-dominant hands.
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Implemented at baseline (T0) and after 12 weeks of intervention (T1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Age
Time Frame: At baseline
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Sample characterisation (years)
|
At baseline
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Gender
Time Frame: At baseline
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Sample percentual gender characterisation (male/female/other)
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At baseline
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Years of Parkinson Disease
Time Frame: At baseline
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Sample characterisation (years)
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At baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1171/23ParkinsonHandwriting
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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