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

Primary Purpose

Dystonic Disorders

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Finger Force Manipulandum
Conventional physiotherapy
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dystonic Disorders focused on measuring Focal Dystonia, Writer's cramp

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Ophtalmologique A. de Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Finger individuation training

control

Arm Description

Finger Force Manipulandum

conventional physiotherapy

Outcomes

Primary Outcome Measures

change in writing speed after rehabilitation
number of letters correctly copied in 60 seconds

Secondary Outcome Measures

Full Information

First Posted
August 24, 2016
Last Updated
July 16, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Foundation Jacques and Gloria Gossweiler
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1. Study Identification

Unique Protocol Identification Number
NCT02882334
Brief Title
Finger Individuation Training With a Training Device Versus Conventional Rehabilitation for Writer's Cramp
Acronym
FIDEX
Official Title
Effectiveness Study of Finger Individuation Training by Finger Force Manipulandum (FFM) Compared to Conventional Rehabilitation for Patients With Writer's Cramp
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficultés d'inclure, les patients sont rares
Study Start Date
November 8, 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Foundation Jacques and Gloria Gossweiler

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonic Disorders
Keywords
Focal Dystonia, Writer's cramp

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Finger individuation training
Arm Type
Experimental
Arm Description
Finger Force Manipulandum
Arm Title
control
Arm Type
Active Comparator
Arm Description
conventional physiotherapy
Intervention Type
Device
Intervention Name(s)
Finger Force Manipulandum
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Primary Outcome Measure Information:
Title
change in writing speed after rehabilitation
Description
number of letters correctly copied in 60 seconds
Time Frame
Change from baseline writing speed at week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre BLETON, PhD
Organizational Affiliation
Fondation OPH A de Rothschild
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pavel Lindberg, PhD
Organizational Affiliation
Centre de Psychiatrie et Neurosciences, Inserm U894
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sophie SANGLA, MD
Organizational Affiliation
Fondation OPH A de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Ophtalmologique A. de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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

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