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Posturography-Neuropathy (PONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154540
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE August 14, 2019
First Posted Date  ICMJE November 6, 2019
Last Update Posted Date November 6, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
Posturography (Romberg's quotient) [ Time Frame: Time 0 ; single session ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • 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
  • 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®)
  • 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®)
  • 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®)
  • 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®)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Posturography-Neuropathy
Official Title  ICMJE Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies
Brief Summary If the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. Clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level of impairment, but this has never been clearly demonstrated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neuropathy Demyelinating
Intervention  ICMJE Other: Motion analysis
Gait and posture recording
Study Arms  ICMJE
  • Experimental: demyelinating hereditary neuropathy
    adult patients with demyelinating hereditary neuropathy type CMT 1A.
    Intervention: Other: Motion analysis
  • Experimental: demyelinating inflammatory neuropathy
    adult patients with acquired demyelinating inflammatory neuropathy.
    Intervention: Other: Motion analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Céline TARD, MD 0320445765 ext +33 celine.tard@chru-lille.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154540
Other Study ID Numbers  ICMJE 2017_17
2017-A02861-52 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Céline TARD, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP