- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04154540
Posturography-Neuropathy (PONE)
Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France
- Hôpital Roger Salengro, CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- CMT1A for molecular-proven Group 1 (PMP22 duplication)
- IPDC likely or defined for Group 2
- Able to walk 10 m unassisted
Exclusion Criteria:
- Neurological history other than neuropathy: epilepsy, stroke, dementia
- Pregnant women
- Person under guardianship or trusteeship
- Musculoskeletal conditions other than neuropathy impairing walking abilities
- Major comorbidity considered a contraindication by the investigator (cancer, unstable angor, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: demyelinating hereditary neuropathy
adult patients with demyelinating hereditary neuropathy type CMT 1A.
|
Gait and posture recording
|
|
Experimental: demyelinating inflammatory neuropathy
adult patients with acquired demyelinating inflammatory neuropathy.
|
Gait and posture recording
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Posturography (Romberg's quotient)
Time Frame: Time 0 ; single session
|
Time 0 ; single session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Timed Up and Go test (TUG)
Time Frame: Time 0 ; single session
|
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. the scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls |
Time 0 ; single session
|
|
stride length (in millimeters) parameters
Time Frame: Time 0 ; single session
|
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
|
Time 0 ; single session
|
|
stride time (in seconde) parameters
Time Frame: Time 0 ; single session
|
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
|
Time 0 ; single session
|
|
velocity (meter/seconde) parameters
Time Frame: Time 0 ; single session
|
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
|
Time 0 ; single session
|
|
cadence (step/min) parameters
Time Frame: Time 0 ; single session
|
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
|
Time 0 ; single session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Céline TARD, MD, University Hospital, Lille
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pathologic Processes
- Neuromuscular Diseases
- Chronic Disease
- Disease Attributes
- Genetic Diseases, Inborn
- Autoimmune Diseases
- Immune System Diseases
- Peripheral Nervous System Diseases
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Neurodegenerative Diseases
- Congenital Abnormalities
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Polyradiculoneuropathy
- Hereditary Sensory and Motor Neuropathy
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Charcot-Marie-Tooth Disease
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Other Study ID Numbers
- 2017_17
- 2017-A02861-52 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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