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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

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.

Condition or disease Intervention/treatment Phase
Neuropathy Demyelinating Other: Motion analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: demyelinating hereditary neuropathy
adult patients with demyelinating hereditary neuropathy type CMT 1A.
Other: Motion analysis
Gait and posture recording

Experimental: demyelinating inflammatory neuropathy
adult patients with acquired demyelinating inflammatory neuropathy.
Other: Motion analysis
Gait and posture recording




Primary Outcome Measures :
  1. Posturography (Romberg's quotient) [ Time Frame: Time 0 ; single session ]

Secondary Outcome Measures :
  1. 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


  2. 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®)

  3. 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®)

  4. 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®)

  5. 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®)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154540


Contacts
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Contact: Céline TARD, MD 0320445765 ext +33 celine.tard@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHU
Lille, France
Principal Investigator: Céline TARD, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Céline TARD, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04154540    
Other Study ID Numbers: 2017_17
2017-A02861-52 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Gait
Balance
Posture
Charcot-Marie-Tooth
Chronic inflammatory demyelinating polyneuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases