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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03329872
Other study ID # 14 7321 03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2014
Est. completion date April 2019

Study information

Verified date July 2019
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 976
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
data collection about symptoms without any specific clinical or biological intervention

Locations

Country Name City State
France CHU de Toulouse Toulouse Midi-Pyrénées

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Toulouse Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurologic symptoms Data collection Each year until five years
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