Clinical trial NCT06693401: Forensic Handwriting Analysis in People with Parkinson's Disease - Pilot Study
Official title: Forensic Analysis of Dynamic Handwriting Characteristics After Rehabilitation Intervention in People with Parkinson's Disease - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Forensic Characterization
Occupational Therapy
Physiotherapy
Graphoscopic Assessment
Dynamic Features
Lead sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Absolute Size
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Horizontal Size (HS)
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Vertical Size
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Average Absolute Velocity
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Duration
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Relative Pen-Down Duration
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Average Pen Pressure
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Normalized Jerk
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Parkinson Disease Questionnaire 8 (PDQ-8)
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
measure: Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: Implemented at baseline (T0) and after 12 weeks of intervention (T1)
Secondary outcomes:
measure: Age
timeFrame: At baseline
measure: Gender
timeFrame: At baseline
measure: Years of Parkinson Disease
timeFrame: At baseline
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Egas Moniz School of Health and Science
state: Monte de Caparica
Study officials:
References: