Handwriting Interventions for People With Parkinson's

Sponsor

Oxford Brookes University (Other)

Overall Status

Suspended

CT.gov ID

NCT03369587

Collaborator

European Parkinson's Therapy Centre (Other)

Enrollment

Location

Arms

60.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: Handwriting Practice	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A phase II exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessmentsA phase II exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessments

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessor Blind to group allocation

Primary Purpose:

Treatment

Official Title:

Handwriting Interventions for People With Parkinson's

Actual Study Start Date :

Nov 2, 2017

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Handwriting Practice Self-directed home handwriting practice daily for 6 weeks
Active Comparator: 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.	Behavioral: Handwriting Practice Self-directed home handwriting practice daily for 6 weeks

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Handwriting Practice

Self-directed home handwriting practice daily for 6 weeks

Active Comparator: 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.

Behavioral: Handwriting Practice

Self-directed home handwriting practice daily for 6 weeks

Outcome Measures

Primary Outcome Measures

Micrograpthia: Area of 'el' 8 character text sequence writing task [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 [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 [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'
Writing amplitude: Area of the both 'lascia' contained in an Italian proverb [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

Secondary Outcome Measures

Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task [6 weeks]
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
Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task [12 weeks]
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
Legibility of Free writing [6 weeks]
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
Legibility of Free writing [12 weeks]
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
EQ-5D-5L [6 weeks]
Standardized Instrument to measure health outcome
EQ-5D-5L [12 weeks]
Standardized Instrument to measure health outcome
Micrograpthia: Area of 'el' 8 character text sequence writing task [12 weeks]
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society [12 weeks]
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?'
Writing speed: Time taken to write an Italian proverb [12 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'
Writing amplitude: Area of the both 'lascia' contained in an Italian proverb [12 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	European Parkinson's therapy centre	Darfo Boario Terme	Brescia	Italy	25041

Sponsors and Collaborators

Oxford Brookes University
European Parkinson's Therapy Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Johnny Collett, Senior Research Fellow, Oxford Brookes University

ClinicalTrials.gov Identifier:

NCT03369587

Other Study ID Numbers:

171073

First Posted:

Dec 12, 2017

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Johnny Collett, Senior Research Fellow, Oxford Brookes University

Handwriting, Micrographia

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Sep 16, 2021