Handwriting Interventions for People With Parkinson's

NCT ID: NCT03369587

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2022-04-21

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. 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Handwriting Practice

Intervention Type: BEHAVIORAL

Self-directed home handwriting practice daily for 6 weeks

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.

Group Type: ACTIVE_COMPARATOR

Handwriting Practice

Intervention Type: BEHAVIORAL

Self-directed home handwriting practice daily for 6 weeks

Interventions

Handwriting Practice

Self-directed home handwriting practice daily for 6 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Parkinson's Therapy Centre

UNKNOWN

Sponsor Role: collaborator

Oxford Brookes University

OTHER

Sponsor Role: lead

Responsible Party

Dr Johnny Collett

Senior Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

European Parkinson's therapy centre

Darfo Boario Terme, Brescia, Italy

Countries

Italy

Other Identifiers

171073

Identifier Type: -

Identifier Source: org_study_id