- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02882334
Finger Individuation Training With a Training Device Versus Conventional Rehabilitation for Writer's Cramp (FIDEX)
July 16, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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
Status
Terminated
Conditions
Intervention / Treatment
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.
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSA_2016_15
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.
Clinical Trials on Dystonic Disorders
-
Fondation Ophtalmologique Adolphe de RothschildTerminated
-
National Institute of Neurological Disorders and...CompletedHealthy | Dystonic DisorderUnited States
-
National Institute of Neurological Disorders and...Completed
-
Medy-ToxCompletedDystonia | Dystonic DisorderKorea, Republic of
-
University Health Network, TorontoDystonia Medical Research FoundationUnknownFocal Hand Dystonia | Writer's Cramp | Musician's Dystonia | Dystonic CrampCanada
-
Fondation Ophtalmologique Adolphe de RothschildInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedFocal Dystonia | Writer's Cramp | Dystonic DisorderFrance
-
King's College LondonImperial College London; Guy's and St Thomas' NHS Foundation Trust; University... and other collaboratorsNot yet recruitingDystonia | Dystonia; Idiopathic | Dystonia, Primary | Dystonia, Secondary | Dystonic Cerebral Palsy
-
All India Institute of Medical Sciences, New DelhiNot yet recruiting
-
Boston Scientific CorporationRecruitingDystoniaGermany, United Kingdom, Italy, Belgium, Hungary, Israel, Netherlands, Poland, Russian Federation, Spain, Korea, Republic of
Clinical Trials on Finger Force Manipulandum
-
Fondation Ophtalmologique Adolphe de RothschildInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedFocal Dystonia | Writer's Cramp | Dystonic DisorderFrance
-
University Hospital of Mont-GodinneRecruiting
-
University of California, IrvineCompleted
-
NorthShore University HealthSystemRecruitingHypermobility of Interphalangeal Joints | Swan-Neck DeformityUnited States
-
VA Office of Research and DevelopmentUniversity of IowaCompleted
-
Acutus MedicalCompletedTypical Atrial FlutterBelgium, United States, United Kingdom
-
University of BaghdadCompletedGingival Diseases | Tooth Diseases | Root Resorption | Orthodontic Appliance Complication | Orthodontic Pathological Resorption of External Root | Tooth PlaqueIraq
-
Centre Hospitalier Departemental VendeeCompletedNutritive ValueFrance
-
Ataturk UniversityNot yet recruiting
-
Biruni UniversityCompleted