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

Tracking Information
First Received Date ^ICMJE	January 12, 2009
Last Updated Date	January 12, 2009
Start Date ^ICMJE	January 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 12, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 12, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients
Official Title ^ICMJE	Not Provided
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.
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Facioscapulohumeral Muscular Dystrophy
Intervention ^ICMJE	Procedure: electrostimulation Electrostimulation of shoulder girdle and quadriceps muscles in facioscapulohumeral muscular dystrophy patients
Study Arm (s)	Experimental: 1 Electrostimulation of the muscles of the scapular belt and the femoris quadristocks Intervention: Procedure: electrostimulation
Publications *	Colson SS, Benchortane M, Tanant V, Faghan JP, Fournier-Mehouas M, Benaïm C, Desnuelle C, Sacconi S. Neuromuscular electrical stimulation training: a safe and effective treatment for facioscapulohumeral muscular dystrophy patients. Arch Phys Med Rehabil. 2010 May;91(5):697-702.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	9
Completion Date	July 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00821548
Other Study ID Numbers ^ICMJE	07-CIR-01
Has Data Monitoring Committee	No
Responsible Party	Centre Hospitalier Universitaire de Nice - Estelle MARTINEZ
Study Sponsor ^ICMJE	Centre Hospitalier Universitaire de Nice
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre Hospitalier Universitaire de Nice
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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