An interventional study of Current flow between sensory and motor threshold and Current intensity upper of motor threshold by Kneehab XP technology in Primary Disease Facioscapulohumeral Dystrophy (FSHD), sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care
Facioscapulohumeral muscular dystrophy (FSHD) is an autosomal dominant disease characterized by progressive weakness and atrophy of specific skeletal muscles. One of the major problems of patients affected by FSHD is the limitation in performing daily activities induced by the progressive muscle weakness. This sedentary lifestyle can cause a "debilitative cycle," and neuromuscular deconditioning can even aggravate the muscular deficiencies. Recent studies have indicated the safety and the effectiveness of moderate aerobic training programs in patients with FSHD. However, these training programs have limited applicability in patients with more severe muscular weakness. Artificial strength training by means of neuromuscular electrical stimulation (NMES) appears to be a promising rehabilitation strategy for FSHD patients suffering from neuromuscular disorders. Therefore we propose to investigate the feasibility, safety, and effectiveness of NMES strength training to counteract quadriceps muscle weakness in patients affected by FSHD.
NMES will be delivered to both quadriceps by means of a Kneehab® XP device, which is an innovative and clinically-proven garment-based product designed specifically to treat quadriceps muscle atrophy. The main NMES current parameters are: 50-Hz frequency, 100-400 µs pulse duration, 5:10-second on:off time. Each session will last approximately 20 minutes and will be repeated 5 days/week for a total duration of the treatment program of 3 months.
University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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Exclusion Criteria:
The current intensity is generally defined between the sensory and motor threshold (patients feel the power but no visible muscle contraction will be obtained).
Other: Current flow between sensory and motor threshold
Tthe current intensity must always meet and exceed the motor threshold (patients feel the current and quadriceps muscle will contract a visible and quantifiable if possible).
Device: Current intensity upper of motor threshold by Kneehab XP technology
Artificial strength training by means of neuromuscular electrical stimulation (NMES)
Artificial strength training by means of neuromuscular electrical stimulation (NMES)
Maximal voluntary contraction (MVC) strength of the quadriceps
Time frame: At 3 months
Effect of NEMS on the quality of life (SF36 questionnaire)
Time frame: At 3 months
Effect of NMES on the quadriceps endurance evaluated in a dynamic test against a charge equal to 30% of maximal isometric force.
Time frame: At 3 months
Evaluation of the body composition by bioelectric impedance analysis (BIA) after NMES effect
Time frame: At 3 months
Effect of NMES on the bone mineral density by dual energy X-ray absorptiometry (DEXA)
Time frame: At 3 months
Effect of NMES on the oxidative stress markers in blood and urine by blood and urine tests
Time frame: At 3 months
This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier