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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00821548
Other study ID # 07-CIR-01
Secondary ID
Status Completed
Phase N/A
First received January 12, 2009
Last updated January 12, 2009
Start date January 2008
Est. completion date July 2008

Study information

Verified date January 2009
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms

  • Facioscapulohumeral Muscular Dystrophy
  • Muscular Dystrophies
  • Muscular Dystrophy, Facioscapulohumeral

Intervention

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

Locations

Country Name City State
France CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. No
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