Handwriting Interventions for People With Parkinson's

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

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

Setting: The intervention will be carried out at home

Sample size: This study is not designed to determine efficacy. The aim to recruit a total of 50 people (25 people per group) in order to estimate the effects on outcome measures and achieve the aims of this exploratory trial.

Assessment: Participants will be asked to follow their usual Parkinson's medication regime and if they have ON and OFF periods, assessments will be carried out during ON state.

Duration and follow-up: the assessment is schedule 0Weeks (baseline), 6weeks (end intervention) and 12weeks (follow up). Assessments will be carried out by a researcher blind to trial arm allocation using all outcome measures.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Handwriting Practice

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Brescia
    • Darfo Boario Terme, Brescia, Italy, 25041
      • European Parkinson's therapy centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diverging lines; 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; Self-directed home handwriting practice daily for 6 weeks
Active Comparator: Parallel lines; 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; Self-directed home handwriting practice daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task	Area (maximum height x maximum width) of handwritten cursive 'elelelel' character sequence performed concurrently with cognative task (serial 3 subtraction). Measured to the nearest of 0.5mm	6 weeks
Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task	Area (maximum height x maximum width) of handwritten cursive 'elelelel' character sequence performed concurrently with cognative task (serial 3 subtraction). Measured to the nearest of 0.5mm	12 weeks
Legibility of Free writing	Ratio between total number of words written and total number of legible words written during a 5 minutes of free writing task: A reflection on the day	6 weeks
Legibility of Free writing	Ratio between total number of words written and total number of legible words written during a 5 minutes of free writing task: A reflection on the day	12 weeks
EQ-5D-5L	Standardized Instrument to measure health outcome	6 weeks
EQ-5D-5L	Standardized Instrument to measure health outcome	12 weeks
Micrograpthia: Area of 'el' 8 character text sequence writing task	Area (maximum height x maximum width) of handwritten cursive 'elelelel' character	12 weeks
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society	0-4 scale (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?'	12 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'	12 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	12 weeks

Collaborators and Investigators

• Sponsor: Oxford Brookes University
• Collaborators: European Parkinson's Therapy Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): April 21, 2022

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Handwriting, Micrographia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 171073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No