Forensic Handwriting Analysis in People with Parkinson's Disease - Pilot Study

NCT06693401 | Completed

• 1 other identifier: 1171/23ParkinsonHandwriting
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Forensic Characterization; Occupational Therapy; Physiotherapy; Graphoscopic Assessment; Dynamic Features

Outcome Measures

Primary Outcomes (11)

• Absolute Size

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Horizontal Size (HS)

  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)

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Vertical Size

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Average Absolute Velocity

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Duration

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Relative Pen-Down Duration

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Average Pen Pressure

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Normalized Jerk

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Parkinson Disease Questionnaire 8 (PDQ-8)

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)

  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).

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

• Jebsen-Taylor Hand Function Test (JTHFT)

  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.

  Implemented at baseline (T0) and after 12 weeks of intervention (T1)

Secondary Outcomes (3)

• Age

  At baseline

• Gender

  At baseline

• Years of Parkinson Disease

  At baseline

Study Arms (2)

Physiotherapy programme

ACTIVE COMPARATOR

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.

Other: Control Group: conventional physiotherapy programme

Physiotherapy programme + Occupational Therapy programme

EXPERIMENTAL

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.

Other: Intervention group: PD rehabilitation complemented with Occupational Therapy programme

Interventions

Intervention group: PD rehabilitation complemented with Occupational Therapy programme OTHER

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: 1. 2 types of handwriting exercises, namely for tracing the upper and lower-case letters of the alphabet guided by dotted lines and writing a sentence with and without spatial boundaries, in Portuguese language (to be performed for about 45 minutes, three times a week) and; 2. 4 groups of fine motor tasks exercises, namely for hand manipulation (2 exercises), finger isolation (3 exercises), finger flexion and extension (2 exercises) and coordination (1 exercise). All exercises were performed 10 times, in triplicate, for each hand on a regular basis of 2-3 times per week.

Physiotherapy programme + Occupational Therapy programme

Control Group: conventional physiotherapy programme OTHER

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.

Physiotherapy programme

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (1)

Egas Moniz School of Health and Science

Almada, Monte de Caparica, 2829-699, Portugal

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Physiotherapy Intervention rehabilitation program was implemented in both study groups in accordance to the usual physiotherapeutic rehabilitation approach through a programme according to the European and American Guidelines for Physical Therapy in Parkinson's Disease, with 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. Occupational Therapy rehabilitation program was implemented only in the Intervention Group, through handbooks for handwriting occupational therapy exercises in Portuguese language, with exercises to be performed for about 45 minutes, three times a week. Each participant was offered a kit with all the materials needed to perform the handwriting and fine motor skills exercises (1 ping-pong ball, 1 anti-stress ball, 1 plastic coin, 2 rubber bands, 2 beans and 10 paper clips).

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: November 18, 2024
• Study Start: March 14, 2023
• Primary Completion: July 21, 2023
• Study Completion: December 20, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

PT (1)