Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects (FFM_CT)

Writer's cramp is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. Patients with Writer's cramp also have difficulty in fine control of grip force.

The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by each fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Different tasks have been developed to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.

The aim of this study is to assess if developed tasks allow to precisely characterize writer's cramp condition in terms of abilities aforementioned.

To do so, performance of 20 writer's cramp patients in the developed task will be compared with performance of 20 control participants (matched in age, sex and writing hand) in the same tasks.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

      • Paris, France, 75019
        • Fondation A 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria for patients with writer's cramp

  • Patient with writer's cramp and writing speed <140 letters / min
  • Writer's cramp focal dystonia specific to the task of writing
  • Patient treated or not with botulinum toxin injection
  • Person having attended school in French

Non inclusion criteria for patients with writer's cramp

  • Patients whose writer's cramp has no impact on the handwriting and has kept a writing speed> 140 letters per minute.
  • Tremor of writing
  • Neurological condition other than writer's cramp (eg Parkinson's syndrome)
  • Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up

Inclusion criteria for control subjects

•> 18 years old

  • Without writer's cramp
  • Person having attended school in French

Non inclusion criteria for control subjects

  • Tremor of writing
  • Neurological condition other than writer's cramp (eg Parkinson's syndrome)
  • Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up

Matching criteria between cases and control patients

  • Age (± 5 years)
  • Gender
  • Hand writing

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with writer's cramp
Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.
Other: Control subjects
Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing
Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manual dexterity by the FFM
Time Frame: Inclusion
Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject
Inclusion

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jean-Pierre BLETON, PhD, Fondation 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)

October 1, 2018

Primary Completion (Actual)

July 19, 2019

Study Completion (Actual)

July 19, 2019

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 20, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

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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