Handwriting Interventions for People With Parkinson's

Parkinson Disease Clinical Trial

Official title:

Handwriting Interventions for People With Parkinson's

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03369587
• Other study ID #: 171073
• Status: Terminated
• Phase: Phase 2
• Start date: November 2, 2017
• Est. completion date: April 21, 2022

Study information

• Verified date: July 2023
• Source: Oxford Brookes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: April 21, 2022
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Handwriting Practice
Self-directed home handwriting practice daily for 6 weeks

Locations

Country	Name	City	State
Italy	European Parkinson's therapy centre	Darfo Boario Terme	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Brookes University	European Parkinson's Therapy Centre

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	EQ-5D-5L	Standardized Instrument to measure health outcome	6 weeks
Secondary	EQ-5D-5L	Standardized Instrument to measure health outcome	12 weeks
Secondary	Micrograpthia: Area of 'el' 8 character text sequence writing task	Area (maximum height x maximum width) of handwritten cursive 'elelelel' character	12 weeks
Secondary	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
Secondary	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
Secondary	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