Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controled Clinical Trial (NEMS and FSHD)

May 7, 2019 updated by: University Hospital, Montpellier

Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controlled Clinical Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Molecular and/or clinical diagnosis for FSHD
  • Vignos scale ≤ 5: Able to walk without help
  • Clinically characterized by quadriceps muscle weakness but with a maximal voluntary contraction (MVC) between 8 and 16 Kg
  • Follow as part of their usual care in the Clinical Physiology Department of the University Hospital of Montpellier
  • Free and informed consent of the patient
  • Patient affiliated or beneficiary of a social security system

Exclusion Criteria:

  • Patient with co-morbidity:pathologies heart, pathologies respiratory, metabolic and endocrine -pathologies, pathologies cancer.
  • Patients treated with drugs could cause muscle side effects or interfere with muscle metabolism.
  • Lesions or skin inflammation at the thighs that can prevent the application of NMES
  • Claustrophobic subject
  • Carrier of intracranial vascular clip, cardiac pacemaker, neurostimulator, cochlear implant, or intraocular metallic foreign
  • Pregnant or nursing women
  • Vulnerable Persons and protected Major or unable to consent
  • Patient in exclusion period relative over another protocol, or for which the annual amount of maximum compensation of € 4,500 has been reached

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
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
Artificial strength training by means of neuromuscular electrical stimulation (NMES)
Active Comparator: Active NMES group
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal voluntary contraction (MVC) strength of the quadriceps
Time Frame: At 3 months
At 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of NEMS on the quality of life (SF36 questionnaire)
Time Frame: At 3 months
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
At 3 months
Evaluation of the body composition by bioelectric impedance analysis (BIA) after NMES effect
Time Frame: At 3 months
At 3 months
Effect of NMES on the bone mineral density by dual energy X-ray absorptiometry (DEXA)
Time Frame: At 3 months
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
At 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2015

Primary Completion (Actual)

September 13, 2016

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UF 9344

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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