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Posturography-Neuropathy (PONE)

Primary Purpose

Neuropathy Demyelinating

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motion analysis
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuropathy Demyelinating focused on measuring Gait, Balance, Posture, Charcot-Marie-Tooth, Chronic inflammatory demyelinating polyneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Hôpital Roger Salengro, CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

demyelinating hereditary neuropathy

demyelinating inflammatory neuropathy

Arm Description

adult patients with demyelinating hereditary neuropathy type CMT 1A.

adult patients with acquired demyelinating inflammatory neuropathy.

Outcomes

Primary Outcome Measures

Posturography (Romberg's quotient)

Secondary Outcome Measures

The Timed Up and Go test (TUG)
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
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
stride time (in seconde) parameters
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
velocity (meter/seconde) parameters
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
cadence (step/min) parameters
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)

Full Information

First Posted
August 14, 2019
Last Updated
February 7, 2023
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04154540
Brief Title
Posturography-Neuropathy
Acronym
PONE
Official Title
Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy Demyelinating
Keywords
Gait, Balance, Posture, Charcot-Marie-Tooth, Chronic inflammatory demyelinating polyneuropathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
demyelinating hereditary neuropathy
Arm Type
Experimental
Arm Description
adult patients with demyelinating hereditary neuropathy type CMT 1A.
Arm Title
demyelinating inflammatory neuropathy
Arm Type
Experimental
Arm Description
adult patients with acquired demyelinating inflammatory neuropathy.
Intervention Type
Other
Intervention Name(s)
Motion analysis
Intervention Description
Gait and posture recording
Primary Outcome Measure Information:
Title
Posturography (Romberg's quotient)
Time Frame
Time 0 ; single session
Secondary Outcome Measure Information:
Title
The Timed Up and Go test (TUG)
Description
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 Frame
Time 0 ; single session
Title
stride length (in millimeters) parameters
Description
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
Time Frame
Time 0 ; single session
Title
stride time (in seconde) parameters
Description
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
Time Frame
Time 0 ; single session
Title
velocity (meter/seconde) parameters
Description
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
Time Frame
Time 0 ; single session
Title
cadence (step/min) parameters
Description
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
Time Frame
Time 0 ; single session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline TARD, MD
Phone
0320445765
Ext
+33
Email
celine.tard@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline TARD, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline TARD, MD

12. IPD Sharing Statement

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Posturography-Neuropathy

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