FFM_CT: Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT03797638

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

Location

Arms

9.6

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dystonic Disorder Focal Dystonia Writer's Cramp	Device: Finger Force Manipuladum (FFM)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Jul 19, 2019

Actual Study Completion Date :

Jul 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with writer's cramp Patients with writer's cramp	Device: Finger Force Manipuladum (FFM) 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	Device: Finger Force Manipuladum (FFM) 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.

Arm

Intervention/Treatment

Experimental: Patients with writer's cramp

Patients with writer's cramp

Device: Finger Force Manipuladum (FFM)

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

Device: Finger Force Manipuladum (FFM)

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.

Outcome Measures

Primary Outcome Measures

Manual dexterity by the FFM [Inclusion]
Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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