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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02882334
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : December 14, 2018
Foundation Jacques and Gloria Gossweiler
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dystonic Disorders Device: Finger Force Manipulandum Other: Conventional physiotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effectiveness Study of Finger Individuation Training by Finger Force Manipulandum (FFM) Compared to Conventional Rehabilitation for Patients With Writer's Cramp
Actual Study Start Date : November 8, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Finger individuation training
Finger Force Manipulandum
Device: Finger Force Manipulandum
Active Comparator: control
conventional physiotherapy
Other: Conventional physiotherapy

Primary Outcome Measures :
  1. change in writing speed after rehabilitation [ Time Frame: Change from baseline writing speed at week 8 ]
    number of letters correctly copied in 60 seconds

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02882334

Contact: Laurence SALOMON, MD, PhD 0033148036431

Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France, 75019
Contact: Laurence SALOMON, MD, PhD    0033148036431   
Principal Investigator: Sophie SANGLA, MD         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Foundation Jacques and Gloria Gossweiler
Study Chair: Jean-Pierre BLETON, PhD Fondation OPH A de Rothschild
Study Director: Pavel Lindberg, PhD Centre de Psychiatrie et Neurosciences, Inserm U894
Principal Investigator: Sophie SANGLA, MD Fondation OPH A de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT02882334     History of Changes
Other Study ID Numbers: SSA_2016_15
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Focal Dystonia
Writer's cramp

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