Analysis of Three-dimensional Movements of the Head in Cervical Dystonia

NCT02069548 | Completed

• 1 other identifier: 2013-A01400-45
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. In addition, the clinical state of cervical dystonia of the patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The investigators will compare the results between control and study groups.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• Range of motion of the voluntary mobility of the cervical spine in the three spatial planes

  Range of motion of the voluntary mobility of the cervical spine in the three spatial planes, measured in patients and matched control subjects

  baseline

Secondary Outcomes (3)

• movements disorders in cervical dystonia

  baseline

• head posture

  baseline

• range of motion

  baseline

Other Outcomes (1)

• score on the Toronto Western Spasmodic torticolis rating scale

  baseline

Study Arms (2)

Cervical dystonia

matched controlled subjects

matched in age (+/- 5 years) and gender

Eligibility Criteria

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

Study Population

Study-group: 30 patients meeting the criteria for cervical dystonia (Spasmodic Torticollis) and without botulinum toxin injections during the last 6 previous months before baseline. Patients will be selected consecutively among the outpatients with movement disorder of 3 study sites: Fondation OPH Rothschild, Salpetriere Hospital and Sainte-Anne Hospital (Paris) Control-group: 30 healthy volunteers matched in age (+/- 5 years) and gender with the 30 CD subjects. They will be selected in Sainte-Anne Hospital (Paris)

You may qualify if:

• Segmental cervical dystonia diagnosed by a neurological specialist in movement disorders

You may not qualify if:

• Neurological pathology other than cervical dystonia such as Parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months
• Neuroleptic treatment in course
• Pregnancy
• breast feeding

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sangla Sophie, MD

  Fondation Ophtalmologique Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 24, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 24, 2016

Record last verified: 2015-06

Locations

FR (1)