Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects (FFM_CT)
Primary Purpose
Dystonic Disorder, Focal Dystonia, Writer's Cramp
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Finger Force Manipuladum (FFM)
Sponsored by
About this trial
This is an interventional other trial for Dystonic Disorder focused on measuring Dystonic Disorder, Focal Dystonia, Writer's Cramp
Eligibility Criteria
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
Sites / Locations
- Fondation A de Rothschild
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Patients with writer's cramp
Control subjects
Arm Description
Patients with writer's cramp
Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing
Outcomes
Primary Outcome Measures
Manual dexterity by the FFM
Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject
Secondary Outcome Measures
Full Information
NCT ID
NCT03797638
First Posted
January 7, 2019
Last Updated
June 20, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03797638
Brief Title
Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects
Acronym
FFM_CT
Official Title
Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
July 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonic Disorder, Focal Dystonia, Writer's Cramp
Keywords
Dystonic Disorder, Focal Dystonia, Writer's Cramp
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with writer's cramp
Arm Type
Experimental
Arm Description
Patients with writer's cramp
Arm Title
Control subjects
Arm Type
Other
Arm Description
Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing
Intervention Type
Device
Intervention Name(s)
Finger Force Manipuladum (FFM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Manual dexterity by the FFM
Description
Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject
Time Frame
Inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre BLETON, PhD
Organizational Affiliation
Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects
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