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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01750710
Other study ID # CHU-0128
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2012
Est. completion date April 28, 2016

Study information

Verified date October 2019
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This exploratory cross-sectional study proposes, firstly, to objectify in a population of Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording of electrical parameters and upper limb muscle strength of the thigh and in a second step, to seek a relationship between the measured parameters.


Description:

Patients suffering from CMT 1A neuropathy will be invited to go through a series of tests such as:

- Electromyography

- Isokinetic test

- Podiatric assessment

- Functional evaluations: Hand dexterity, limbs muscles strength

- Quality of life assessment with questionnaires


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date April 28, 2016
Est. primary completion date April 28, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients older than 18 years

- Diagnosis of Charcot Marie Tooth disease, type 1A confirmed by molecular biology (duplication 17.p11.2)

- Listening and written French

- Agreement after written information, clear and honest about the purpose of the study, the nature of the tests and their possible side effects or bothersome.

- Strength of the quadriceps superior to 2/5 MMT MRC

Exclusion Criteria:

- Presence of other neurological comorbidity

- Presence of coronary artery disease unstabilized

- Peripheral neuropathy of other causes: diabetes, monoclonal gammopathy, malignancy, solid cancer, systemic autoimmune disease (lupus, Sjögren's disease, Wegener sarcoidosis ...), infectious disease (viral hepatitis, HIV ...), drugs known to be responsible for iatrogenic neuropathy.

- Gait trouble of other origin

- Patients unable to give their consent.

- Intellectual deficit that does not allow to comply with tests

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary axonal loss at day 1
Secondary Muscle strength at day 1
Secondary Functional scores at day 1
Secondary Hand testing at day 1
Secondary spatial and temporal parameters of walking at day 1
Secondary Barometric stabilometric podo-static scores at day 1
Secondary Quality of life at day 1
Secondary Fatigue at day 1
Secondary Depression at day 1
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05142059 - Fall Risk Assessment in a Population of Charcot-Marie-Tooth Disease Type 1A (CMT 1A) by Timed Up and Go Test N/A