The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the… (NCT00312793) | Clinical Trial Compass
TerminatedPhase 1/2
The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament
Stopped: the study stopped becaust the sponsor did not wish to proceede with the study
Israel60 participants
Plain-language summary
This study is designed to evaluate the efficacy and safety of Myospare, a non-invasive device, which is connected to the body via electrodes placed in the injured leg. The electrodes which are placed in the middle or upper thigh will stimulate the quadriceps muscle.
Myospare will be installed 1 day after the anterior cruciate ligament (ACL) reconstruction surgery and will be removed after 6 weeks of treatment. The patients will be assigned to two groups:
1. Physiotherapy plus Myospare
2. Only physiotherapy
The hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. Males and females between 18-40 years old.
✓. Subjects who are planning to undergo ACL surgery.
✓. The surgery is performed within 3 weeks - 5 years since the injury.
✓. Ability to follow instructions during the study period.
✓. Signed Informed Consent.
Exclusion criteria
✕. Bi-lateral surgery of the knee
✕. Recurrent ACL surgery (patients who already underwent ACL surgery)
✕. Complex injuries (a combination of posterior and anterior cruciate and lateral ligament injury)
✕. Patients who underwent or are planned to undergo cartilage implantation.
✕. Patients who underwent or are planned to undergo meniscus stitching.
✕
What they're measuring
1
the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device