Handwriting Interventions for People With Parkinson's

Parkinson Disease Clinical Trial

Official title: Handwriting Interventions for People With Parkinson's

Status Terminated

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03369587
• Study type: Interventional
• Source: Oxford Brookes University
• Status: Terminated
• Phase: Phase 2
• Start date: November 2, 2017
• Completion date: April 21, 2022