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

Focal Dystonia Clinical Trial

— FFM_CT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797638
• Other study ID #: SSA_2018_4
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 19, 2019

Study information

• Verified date: June 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorder
• Dystonic Disorders
• Focal Dystonia
• Muscle Cramp
• Spasm
• Writer's Cramp

Intervention

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.

Locations

Country	Name	City	State
France	Fondation A de Rothschild	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manual dexterity by the FFM	Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject	Inclusion