Handwriting Interventions for People With Parkinson's
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Oxford Brookes University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
Study Overview
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:
- Estatimate the effect of the intervention on measures of: Handwriting amplitude (consistent and progressive reduction), hand writing performance and percieved handwriting difficulties.
- Explore the appropriateness of these outcome measures
- Explore the approriateness of eligibilty criteria
- Explore intervention fidelity
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessor Blind to group allocation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Handwriting Practice (Behavioral)
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.
Intervention: Handwriting Practice (Behavioral)
Outcomes
Primary Outcomes
Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
Time Frame: 6 weeks
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
Micrograpthia: Area of 'el' 8 character text sequence writing task
Time Frame: 6 weeks
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character sequence measured to the nearest of 0.5mm
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society Unified Parkinson's Rating Scale
Time Frame: 6 weeks
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?'
Writing speed: Time taken to write an Italian proverb
Time Frame: 6 weeks
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'
Secondary Outcomes
- Micrograpthia: Area of 'el' 8 character text sequence writing task(12 weeks)
- Legibility of Free writing(12 weeks)
- Writing speed: Time taken to write an Italian proverb(12 weeks)
- Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task(12 weeks)
- EQ-5D-5L(12 weeks)
- Writing amplitude: Area of the both 'lascia' contained in an Italian proverb(12 weeks)
- Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society(12 weeks)
- Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task(6 weeks)
- Legibility of Free writing(6 weeks)
- EQ-5D-5L(6 weeks)
Investigators
Dr Johnny Collett
Senior Research Fellow
Oxford Brookes University