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

January 12, 2009
January 12, 2009
January 2008
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients
Not Provided

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Facioscapulohumeral Muscular Dystrophy
Procedure: electrostimulation
Electrostimulation of shoulder girdle and quadriceps muscles in facioscapulohumeral muscular dystrophy patients
Experimental: 1
Electrostimulation of the muscles of the scapular belt and the femoris quadristocks
Intervention: Procedure: electrostimulation
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. doi: 10.1016/j.apmr.2010.01.019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00821548
07-CIR-01
No
Centre Hospitalier Universitaire de Nice - Estelle MARTINEZ
Centre Hospitalier Universitaire de Nice
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nice
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP