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

NCT ID: NCT06693401

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2023-12-20

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.

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Control Group: conventional physiotherapy programme

Intervention Type: 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 + 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.

Group Type: EXPERIMENTAL

Intervention group: PD rehabilitation complemented with Occupational Therapy programme

Intervention Type: 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.

Interventions

Intervention group: PD rehabilitation complemented with Occupational Therapy programme

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.

Intervention Type: OTHER

Control Group: conventional physiotherapy programme

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egas Moniz - Cooperativa de Ensino Superior, CRL

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Egas Moniz School of Health and Science

Almada, Monte de Caparica, Portugal

Countries

Portugal

Other Identifiers

1171/23ParkinsonHandwriting

Identifier Type: -

Identifier Source: org_study_id