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

NCT02882334 | Terminated

• 1 other identifier: SSA_2016_15
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Focal Dystonia; Writer's cramp

Outcome Measures

Primary Outcomes (1)

• change in writing speed after rehabilitation

  number of letters correctly copied in 60 seconds

  Change from baseline writing speed at week 8

Study Arms (2)

Finger individuation training

EXPERIMENTAL

Finger Force Manipulandum

Device: Finger Force Manipulandum

control

ACTIVE COMPARATOR

conventional physiotherapy

Other: Conventional physiotherapy

Interventions

Finger Force Manipulandum DEVICE

Finger individuation training

Conventional physiotherapy OTHER

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Foundation Jacques and Gloria Gossweiler: collaborator

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jean-Pierre BLETON, PhD

  Fondation OPH A de Rothschild

  STUDY CHAIR

• Pavel Lindberg, PhD

  Centre de Psychiatrie et Neurosciences, Inserm U894

  STUDY DIRECTOR

• Sophie SANGLA, MD

  Fondation OPH A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: November 8, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

FR (1)