Handwriting Interventions for People With Parkinson's

NCT03369587 | Terminated Phase 2

• 1 other identifier: 171073
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Problems with handwriting are frustrating and debilitating and affect the majority of people with Parkinson's. Manifest as micrographia it is a distinctive feature of the condition characterised by small handwriting and/or a progressive reduction in size through a sentence\[2\] coupled with a reduction in writing speed and legibility. In Parkinson's impaired automaticity is thought to contribute to handwriting deficits and attention has been shown to improve both 'consistent' (small handwriting) and 'progressive' (progressive reduction in letter size through a sentence) aspects of the symptom. Moreover, recent interventional studies indicate handwriting may be improved through practice. This study is investigating a novel handwriting practice stimulus to improve symptoms of micrograpthia Question: Is a diverging line cued handwriting intervention potentially more effective at improving symptoms of mircograpthia than a parallel line cued handwriting intervention in people with Parkinson's? Specifically, an assessor blind randomised controlled exploratory trial will:

1. 1.Estatimate the effect of the intervention on measures of: Handwriting amplitude (consistent and progressive reduction), hand writing performance and percieved handwriting difficulties.
2. 2.Explore the appropriateness of these outcome measures
3. 3.Explore the approriateness of eligibilty criteria
4. 4.Explore intervention fidelity
5. 5.Explore participants views of the intervention

Conditions

Parkinson Disease

Keywords

Handwriting, Micrographia

Outcome Measures

Primary Outcomes (4)

• Micrograpthia: Area of 'el' 8 character text sequence writing task

  Area (maximum height x maximum width) of handwritten cursive 'elelelel' character sequence measured to the nearest of 0.5mm

  6 weeks

• Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society Unified Parkinson's Rating Scale

  A scale from 0-4 (0: normal: no problems, 4: severe: most or all words cannot be read) asking 'Over the past week, have people usually had trouble reading your handwriting?'

  6 weeks

• Writing speed: Time taken to write an Italian proverb

  Time taken to the nearest 10th second to hand write the sentence (written across one line): 'Chi lascia la via vecchia per la nuova, sa quello che lascia ma non sa quello che trova'

  6 weeks

• Writing amplitude: Area of the both 'lascia' contained in an Italian proverb

  Area (maximum height x maximum width) of 'lascia' contained in handwritten sentence: 'Chi lascia la via vecchia per la nuova, sa quello che lascia ma non sa quello che trova'. Measured to the nearest 0.5mm

  6 weeks

Secondary Outcomes (10)

• Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task

  6 weeks

• Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task

  12 weeks

• Legibility of Free writing

  6 weeks

• Legibility of Free writing

  12 weeks

• EQ-5D-5L

  6 weeks

Study Arms (2)

Diverging lines

EXPERIMENTAL

What: Handwriting practice at home delivered through handwriting workbooks. The workbook consists of diverging lines. Participants will be instructed to write a daily diary (a reflection of their day) aiming for letters letter size to be consistent with the lines. Participant will be instructed to take a long as they need to complete the daily diary and focus and concentrate the handwriting and achieving the size dictated by the lines. They will be asked to do this daily, but at least 5 days a week for 6 weeks. Tailoring and progression: The nature of the handwriting program is that it accounts for individual ability; participant will be asked to write as much as they can during the practice session, whilst concentrating on their handwriting.

Behavioral: Handwriting Practice

Parallel lines

ACTIVE COMPARATOR

What: Handwriting practice at home delivered through handwriting workbooks. The workbook consists of parallel lines. Participants will be instructed to write a daily diary (a reflection of their day) aiming for letters letter size to be consistent with the lines. Participant will be instructed to take a long as they need to complete the daily diary and focus and concentrate the handwriting and achieving the size dictated by the lines. They will be asked to do this daily, but at least 5 days a week for 6 weeks. Tailoring and progression: The nature of the handwriting program is that it accounts for individual ability; participant will be asked to write as much as they can during the practice session, whilst concentrating on their handwriting.

Behavioral: Handwriting Practice

Interventions

Handwriting Practice BEHAVIORAL

Self-directed home handwriting practice daily for 6 weeks

Diverging lines; Parallel lines

Eligibility Criteria

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

You may qualify if:

• Over 18 years old
• Diagnosis of idiopathic Parkinson's disease
• A score of ≤3 on the Hoehn and Yahr scale
• Self-reported problem with handwriting (≥1 UPDRSII, 2.7)
• Able to communicate in Italian
• Following a stable medication regimen (no changes in the last 2 weeks and anticipated changes for the course of the study).

You may not qualify if:

• Severe depression or psychosis (history of),
• reduced cognition that would preclude active involvement or capacity to consent (according to stages outlined in metal capacity act (ie trigger, information, existing diagnosis, functional test))
• Orthopaedic, neurological or other condition that significantly impairs hand function,
• Pregnancy

Sponsors & Collaborators

• Oxford Brookes University: lead
• European Parkinson's Therapy Centre: collaborator

Study Sites (1)

European Parkinson's therapy centre

Darfo Boario Terme, Brescia, 25041, Italy

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: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor Blind to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: A phase II exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessments

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: December 12, 2017
• Study Start: November 2, 2017
• Primary Completion: February 28, 2020
• Study Completion: April 21, 2022
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

IT (1)