Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients
Primary Purpose
Facioscapulohumeral Muscular Dystrophy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electrostimulation
Sponsored by
About this trial
This is an interventional treatment trial for Facioscapulohumeral Muscular Dystrophy focused on measuring facioscapulohumeral muscular dystrophy, electrostimulation, training
Eligibility 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
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Electrostimulation of the muscles of the scapular belt and the femoris quadristocks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00821548
First Posted
January 12, 2009
Last Updated
January 12, 2009
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT00821548
Brief Title
Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facioscapulohumeral Muscular Dystrophy
Keywords
facioscapulohumeral muscular dystrophy, electrostimulation, training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Electrostimulation of the muscles of the scapular belt and the femoris quadristocks
Intervention Type
Procedure
Intervention Name(s)
electrostimulation
Intervention Description
Electrostimulation of shoulder girdle and quadriceps muscles in facioscapulohumeral muscular dystrophy patients
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Nice
City
Nice
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
20434605
Citation
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.
Results Reference
derived
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Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients
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