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

NCT00821548 | Completed

• 1 other identifier: 07-CIR-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Facioscapulohumeral Muscular Dystrophy

Keywords

facioscapulohumeral muscular dystrophy; electrostimulation; training

Outcome Measures

Primary Outcomes (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

  daily, 1, 3 and 5 months

Secondary Outcomes (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

  after 3 months of therapy and at the end of the study, after 5 months.

Study Arms (1)

1

EXPERIMENTAL

Electrostimulation of the muscles of the scapular belt and the femoris quadristocks

Procedure: electrostimulation

Interventions

electrostimulation PROCEDURE

Electrostimulation of shoulder girdle and quadriceps muscles in facioscapulohumeral muscular dystrophy patients

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

Location

Related Publications (1)

• Colson SS, Benchortane M, Tanant V, Faghan JP, Fournier-Mehouas M, Benaim 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.

  PMID: 20434605 DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Facioscapulohumeral

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 13, 2009

Record last verified: 2009-01

Locations

FR (1)