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Handwriting Interventions for People With Parkinson's

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Handwriting Practice
Sponsored by
Oxford Brookes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Handwriting, Micrographia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • European Parkinson's therapy centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diverging lines

Parallel lines

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Micrograpthia: Area of 'el' 8 character text sequence writing task
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
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 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
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
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
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
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
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
Standardized Instrument to measure health outcome
EQ-5D-5L
Standardized Instrument to measure health outcome
Micrograpthia: Area of 'el' 8 character text sequence writing task
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society
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
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
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

Full Information

First Posted
July 18, 2017
Last Updated
July 25, 2023
Sponsor
Oxford Brookes University
Collaborators
European Parkinson's Therapy Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03369587
Brief Title
Handwriting Interventions for People With Parkinson's
Official Title
Handwriting Interventions for People With Parkinson's
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Not feasible to restarted after Covid pandemic - analysis will be on data collected before study suspended
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford Brookes University
Collaborators
European Parkinson's Therapy Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Handwriting, Micrographia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A phase II exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessments
Masking
Outcomes Assessor
Masking Description
Assessor Blind to group allocation
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diverging lines
Arm Type
Experimental
Arm Description
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.
Arm Title
Parallel lines
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Handwriting Practice
Intervention Description
Self-directed home handwriting practice daily for 6 weeks
Primary Outcome Measure Information:
Title
Micrograpthia: Area of 'el' 8 character text sequence writing task
Description
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character sequence measured to the nearest of 0.5mm
Time Frame
6 weeks
Title
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society Unified Parkinson's Rating Scale
Description
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?'
Time Frame
6 weeks
Title
Writing speed: Time taken to write an Italian proverb
Description
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'
Time Frame
6 weeks
Title
Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task
Description
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
Time Frame
6 weeks
Title
Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task
Description
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
Time Frame
12 weeks
Title
Legibility of Free writing
Description
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
Time Frame
6 weeks
Title
Legibility of Free writing
Description
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
Time Frame
12 weeks
Title
EQ-5D-5L
Description
Standardized Instrument to measure health outcome
Time Frame
6 weeks
Title
EQ-5D-5L
Description
Standardized Instrument to measure health outcome
Time Frame
12 weeks
Title
Micrograpthia: Area of 'el' 8 character text sequence writing task
Description
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character
Time Frame
12 weeks
Title
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society
Description
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?'
Time Frame
12 weeks
Title
Writing speed: Time taken to write an Italian proverb
Description
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'
Time Frame
12 weeks
Title
Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
European Parkinson's therapy centre
City
Darfo Boario Terme
State/Province
Brescia
ZIP/Postal Code
25041
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Handwriting Interventions for People With Parkinson's

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