- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03797638
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Fondation A de Rothschild
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Jean-Pierre BLETON, PhD, Fondation A. de Rothschild
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSA_2018_4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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