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Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00821548
First received: January 12, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

The investigators evaluated clinical tolerance, biological tolerance, feasibility and efficacy of daily electrostimulation training of shoulder girdle and quadriceps muscles in 10 patients with facioscapulohumeral muscular dystrophy, the third most common inherited myopathy.


Condition Intervention
Facioscapulohumeral Muscular Dystrophy
 Procedure: electrostimulation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Clinical tolerance evaluated by fatigue and pain analogic scale. Biological tolerance:evaluated by measuring CK values.The feasibility:evaluated by considering monthly average length of sessions, monthly score of participation to sessions [ Time Frame: daily, 1, 3 and 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of electrostimulation training in FSHD patients will be evaluated comparing manual muscle testing, Barré test, quantitative muscle assessment, fatigue severity scale, 6 minutes walking test before the therapy [ Time Frame: after 3 months of therapy and at the end of the study, after 5 months. ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Electrostimulation of the muscles of the scapular belt and the femoris quadristocks
 Procedure: electrostimulation
Electrostimulation of shoulder girdle and quadriceps muscles in facioscapulohumeral muscular dystrophy patients

Detailed Description:

Autosomal dominant FSHD is characterized by selective pattern of muscle involvement. Weakness and atrophy typically involve facial and shoulder girdle muscles, and progressively anterior forearm and foreleg muscles and pelvic girdle muscles.

The physiopatholgical mechanism of this disease, due to a deletion of repeated units named D4Z4 located on 4q35, is still controversial. Up to date, no curative therapy is available for these patients. We proposed in the present study to test feasibility, clinical and biological tolerance and efficacy of shoulder muscle training by electrostimulation in a group of FSHD patients. 10 patients displaying classical FSHD phenotype participate to this study consisting in daily session of shoulder girdle and quadriceps muscles electrostimulation of 23 minutes for a period of 5 months.

We evaluated: clinical tolerance by daily pain and fatigue analogic scales, biological tolerance by measuring CK; feasibility: by measuring the monthly score of participation to sessions; the efficacy by manual muscle testing, quantitative muscle assessment, fatigue severity scale.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 75 years old patient
  • FSHD diagnosis confirmed by molecular biology
  • FSHD clinical phenotype including shoulder girdle and quadriceps involvement
  • Patient with Vignos scale ≤ 5 (patient able to walk)
  • Patient with health insurance
  • Patient that could be followed for at least 6 months

Exclusion Criteria:

  • Patient with monolateral or bilateral scapular omopexia
  • Patient that has already had electrostimulation training
  • Patients with CK values > 5 time normal values
  • Patient that has not signed informed consent
  • Patient with cancer, collagenopathies or others joint diseases
  • Pregnancy and breast-feeding
  • Patient on guardianship or trusteeship.
  • Patient actively participating to other biomedical researches or whose exclusion period is not ended
  • Patient with a formal contraindication to the protocol detected by inclusion examinations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821548

Locations
France
CHU de Nice
Nice, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
  More Information

No publications provided by Centre Hospitalier Universitaire de Nice

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centre Hospitalier Universitaire de Nice - Estelle MARTINEZ
ClinicalTrials.gov Identifier: NCT00821548     History of Changes
Other Study ID Numbers: 07-CIR-01
Study First Received: January 12, 2009
Last Updated: January 12, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nice:
facioscapulohumeral muscular dystrophy
electrostimulation
training

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 22, 2013