Finger Individuation Training With a Training Device Versus Conventional Rehabilitation for Writer's Cramp (FIDEX)

Effectiveness Study of Finger Individuation Training by Finger Force Manipulandum (FFM) Compared to Conventional Rehabilitation for Patients With Writer's Cramp

Writer's cramp (WC) 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. WC patients also have difficulty in fine control of grip force. However, some previous studies indicate positive effects of individual finger movement training in WC although these studies lacked enhanced visual feedback of activations in 'stationary' fingers. The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by the fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary' fingers can be displayed on-line providing enhanced feedback on independence of finger movements. The aim of this study is to test the effectiveness of finger individuation training using the FFM to improve symptoms in WC patients.

Study Overview

Study Type

Interventional

Enrollment (Actual)

26

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 Ophtalmologique 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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders
  • handwriting speed < 140 letters per minute
  • simple or complex writer's cramp
  • scholarship in French language
  • absence of treatment by botulinum neurotoxin, or last injection > 3 months
  • age > 18 and < 71 years
  • informed consent
  • medical insurance coverage

Exclusion Criteria:

  • writer's cramp with no impact on writing
  • writing tremor
  • other neurological disease with effect on writing
  • pain or traumatism of the limb used for writing, requiring medical or surgical treatment in the last preceding months
  • 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

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Finger individuation training
Finger Force Manipulandum
ACTIVE_COMPARATOR: control
conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in writing speed after rehabilitation
Time Frame: Change from baseline writing speed at week 8
number of letters correctly copied in 60 seconds
Change from baseline writing speed at week 8

Collaborators and Investigators

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

Investigators

  • Study Director: Pavel Lindberg, PhD, Centre de Psychiatrie et Neurosciences, Inserm U894

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)

November 8, 2016

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

December 1, 2020

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)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

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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