Clinical trial NCT03369587: Handwriting Interventions for People With Parkinson's
Official title: Handwriting Interventions for People With Parkinson's
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Handwriting, Micrographia
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: European Parkinson's Therapy Centre
First posted: 2017-12-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A phase II exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessments
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Micrograpthia: Area of 'el' 8 character text sequence writing task
timeFrame: 6 weeks
measure: Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society Unified Parkinson's Rating Scale
timeFrame: 6 weeks
measure: Writing speed: Time taken to write an Italian proverb
timeFrame: 6 weeks
measure: Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
timeFrame: 6 weeks
Secondary outcomes:
measure: Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task
timeFrame: 6 weeks
measure: Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task
timeFrame: 12 weeks
measure: Legibility of Free writing
timeFrame: 6 weeks
measure: Legibility of Free writing
timeFrame: 12 weeks
measure: EQ-5D-5L
timeFrame: 6 weeks
measure: EQ-5D-5L
timeFrame: 12 weeks
measure: Micrograpthia: Area of 'el' 8 character text sequence writing task
timeFrame: 12 weeks
measure: Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society
timeFrame: 12 weeks
measure: Writing speed: Time taken to write an Italian proverb
timeFrame: 12 weeks
measure: Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Darfo Boario Terme
country: Italy
facility: European Parkinson's therapy centre
state: Brescia
Study officials:
References: