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

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ClinicalTrials.gov Identifier: NCT02882295
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

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.


Condition or disease Intervention/treatment
Dystonic Disorder Other: Validation of a handwriting scale

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Actual Study Start Date : August 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. hand-writing speed [ Time Frame: immediate ]
    speed and accuracy of handwriting



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients suffering from writer's cramp and healthy subjects, age and gender matched
Criteria

Inclusion Criteria:

  • age > 18 and < 71 years
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882295


Contacts
Contact: Laurence SALOMON, MD, PhD 0033148036431 lsalomon@for.paris

Locations
France
Fondation Ophtalmique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Sophie Sangla, MD       ssangla@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Study Director: Jean-Pierre BLETON, PhD Fondation OPH A de Rothschild
Principal Investigator: Sophie SANGLA, MD Fondation OPH A de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02882295     History of Changes
Other Study ID Numbers: SSA_2016_10
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Dystonic Disorders
Dystonia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms