Validation of the Zigzag Tracking Task Test for the Evaluation of Handwriting Difficulties in Writer's Cramp (LabyDys)

April 7, 2022 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm.

Clinical scales currently use for the assessment of WC fail to accurately reflect changes in the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections and / or retraining therapy).

The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. This timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). The investigators propose to validate the ZZTT for the assessment of the handwriting gesture of WC.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

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

  • France
      • Paris, France, 75019
        • Fondation ophtalmique Adolphe de Rothschild

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients suffering from writer's cramp and healthy subjects, age and gender matched

Description

Inclusion Criteria:

  • scholarship in French language, at least until 16 years old
  • writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders)
  • prescription of botulinum neurotoxin injection
  • prescription de novo or absence of injection in the last 3 months
  • informed consent
  • medical insurance coverage

Exclusion Criteria:

  • writing tremor
  • -other neurological disease with effect on handwriting
  • pain or traumatism of the upper limb, with effect on handwriting
  • non-corrected visual disturbances
  • patient living outside the region where the study will be held (Ile-de-France)
  • participation in another research with a potential impact on evaluation criteria
  • pregnant or breast feeding patient
  • patient under judiciary protection

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
writer's cramp
patients assessed without, then with Botulinum Neurotoxin injections
Other: Validation of a handwriting scale
control
age and gender matched
Other: Validation of a handwriting scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hand-writing speed
Time Frame: immediate
speed and accuracy of handwriting
immediate

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Study Director: Jean-Pierre BLETON, PhD, Fondation OPH A de Rothschild

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)

July 5, 2016

Primary Completion (Actual)

November 15, 2017

Study Completion (Actual)

November 15, 2017

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSA_2016_10

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.

Clinical Trials on Dystonic Disorder

Clinical Trials on Validation of a handwriting scale

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe