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Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin (PPS and IGIV)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004390
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Our study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital

Condition or disease
Post-Poliomyélitis Syndrom

Detailed Description:

Patients are admitted to a multidisciplinary consultation (neurologist, PMK) to validate the indication of treatment with IGIV. Realization of a pre-therapeutic evaluation in the department of MPR on the criteria of judgment, then the patient is admitted in a service of neurology to benefit from the cure of IGIV. The patient is then re-admitted to a PMR service for post-treatment evaluation.

Collection of data retrospectively.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin: a Retrospective Study of Efficacy on Clinical and Isokinetic Criteria
Actual Study Start Date : June 28, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 30, 2019





Primary Outcome Measures :
  1. Muscular strength [ Time Frame: 5 months ]
    Muscular strength with isokinetic


Secondary Outcome Measures :
  1. Walking perimeter [ Time Frame: 5 months ]
    Walking perimeter with walking test (6 minutes)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
15 men and 11 women with Diagnosis of PPS
Criteria

Inclusion Criteria:

  • Diagnosis of PPS
  • Pre- and post-therapeutic evaluation carried out
  • Data transcribed in the computerized patient file

Exclusion Criteria:

  • No walking patient

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): NCT04004390


Locations
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France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: MOIZIARD Vincent, intern University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04004390    
Other Study ID Numbers: RECHMPL19_0322
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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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, Montpellier:
Pre- and post-therapeutic evaluation carried out
Data transcribed in the computerized patient file
post-poliomyelitis syndrome
Intravenous immunoglobulins
walking test
isokinetics
Additional relevant MeSH terms:
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Poliomyelitis
Postpoliomyelitis Syndrome
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neurodegenerative Diseases