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

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ClinicalTrials.gov Identifier: NCT00821548
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Facioscapulohumeral Muscular Dystrophy Procedure: electrostimulation

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Primary Completion Date : July 2008
Study Completion Date : July 2008


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00821548


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

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
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: January 2009

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