Posturography-Neuropathy

Neuropathy Demyelinating Clinical Trial

— PONE  

Official title:

Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04154540
• Other study ID #: 2017_17
• Secondary ID: 2017-A02861-52
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Céline TARD, MD
• Phone: 0320445765
• Email: celine.tard[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Neuropathy Demyelinating
• Peripheral Nervous System Diseases

Intervention

Other:
• Motion analysis
Gait and posture recording

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posturography (Romberg's quotient)		Time 0 ; single session
Secondary	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	Time 0 ; single session
Secondary	stride length (in millimeters) parameters	Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)	Time 0 ; single session
Secondary	stride time (in seconde) parameters	Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)	Time 0 ; single session
Secondary	velocity (meter/seconde) parameters	Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)	Time 0 ; single session
Secondary	cadence (step/min) parameters	Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)	Time 0 ; single session