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

NCT02882295 | Terminated

• 1 other identifier: SSA_2016_10
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonic Disorder

Outcome Measures

Primary Outcomes (1)

• hand-writing speed

  speed and accuracy of handwriting

  immediate

Study Arms (2)

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

Interventions

Validation of a handwriting scale OTHER

control; writer's cramp

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jean-Pierre BLETON, PhD

  Fondation OPH A de Rothschild

  STUDY DIRECTOR

• Sophie SANGLA, MD

  Fondation OPH A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: July 5, 2016
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

FR (1)