Handwriting Interventions for People With Parkinson's

July 25, 2023 updated by: Dr Johnny Collett, Oxford Brookes University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Brescia
      • Darfo Boario Terme, Brescia, Italy, 25041
        • European Parkinson's therapy centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 weeks
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?'
6 weeks
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'
6 weeks
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
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Micrograpthia under cognative motor interference: 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 performed concurrently with cognative task (serial 3 subtraction). Measured to the nearest of 0.5mm
6 weeks
Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task
Time Frame: 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
12 weeks
Legibility of Free writing
Time Frame: 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
6 weeks
Legibility of Free writing
Time Frame: 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
12 weeks
EQ-5D-5L
Time Frame: 6 weeks
Standardized Instrument to measure health outcome
6 weeks
EQ-5D-5L
Time Frame: 12 weeks
Standardized Instrument to measure health outcome
12 weeks
Micrograpthia: Area of 'el' 8 character text sequence writing task
Time Frame: 12 weeks
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character
12 weeks
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society
Time Frame: 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?'
12 weeks
Writing speed: Time taken to write an Italian proverb
Time Frame: 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'
12 weeks
Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
Time Frame: 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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oxford Brookes University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Parkinson's Therapy Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 171073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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