Finger Individuation Training With a Training Device Versus Conventional Rehabilitation for Writer's Cramp

NCT ID: NCT02882334

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-08
• Study Completion Date: 2020-12-31

Brief Summary

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.

Conditions

Dystonic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Finger individuation training

Finger Force Manipulandum

Group Type: EXPERIMENTAL

Finger Force Manipulandum

Intervention Type: DEVICE

control

conventional physiotherapy

Group Type: ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type: OTHER

Interventions

Finger Force Manipulandum

Intervention Type: DEVICE

Conventional physiotherapy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation Jacques and Gloria Gossweiler

UNKNOWN

Sponsor Role: collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre BLETON, PhD

Role: STUDY_CHAIR

Fondation OPH A de Rothschild

Pavel Lindberg, PhD

Role: STUDY_DIRECTOR

Centre de Psychiatrie et Neurosciences, Inserm U894

Sophie SANGLA, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation OPH A de Rothschild

Locations

Fondation Ophtalmologique A. de Rothschild

Paris, , France

Countries

France

Other Identifiers

SSA_2016_15

Identifier Type: -

Identifier Source: org_study_id