NCT03329872

Brief Summary

Neuro-orthopedics corresponds to the evaluation and therapeutic management of the orthopedic consequences of damage to the central or peripheral nervous system. In case of neurological impairment, there may be joint, motor, sensory and cognitive impairments that limit the patient's activities. The management of these orthopedic problems falls within the specific framework of neuro-orthopedics because in the presence of neurological, problems are different and more complex than in classical orthopedics. In this context, a well-conducted evaluation is a prerequisite for appropriate treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
976

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

4.4 years

First QC Date

August 21, 2017

Last Update Submit

July 15, 2019

Conditions

Keywords

Neuro-OrthopedicsRegister

Outcome Measures

Primary Outcomes (1)

  • Neurologic symptoms

    Data collection

    Each year until five years

Study Arms (1)

Patients group

Patients follow-up in hospital will have data collection

Other: Data collection

Interventions

data collection about symptoms without any specific clinical or biological intervention

Patients group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with central or peripheral nervous system disorders with orthopedic consequences.

You may qualify if:

  • Patient with a neurological condition that benefits:
  • An injection of botulinum toxin in the context of spasticity : about 20 / week
  • Pre or post-therapeutic clinical evaluation (botulinum toxin or surgery): approximately 10 / week
  • Clinical or instrumental evaluation of the walking or upper limb (Physiological Functional Explorations): about 10 / week
  • A medical and surgical multidisciplinary consultation about spasticity : about 15 / month
  • A discussion during neuroorthopedic multidisciplinary consultation meeting about the patient's file and anomalies of walking: about 8 / month
  • Implementation of a Baclofen pump (Neurosurgery): about 2 / month
  • Functional surgery of the upper or lower limb (locomotor institute, orthopedic surgery and traumatology): about 4 / sem

You may not qualify if:

  • Patient (or the legal representative) who opposes the data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, Midi-Pyrénées, 31059, France

Location

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David Gasq

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

November 6, 2017

Study Start

November 1, 2014

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations