NCT00312793

The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament

Phase 2 Study to Evaluate the Efficacy and Safety of Electronic Stimulation of the Quadriceps Muscle in the Thigh by the MyoSpare Device, in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament (ACL)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Injuries

Interventions

Type	Name	Description
DEVICE	stimulation of the quadriceps muscle with Myospare

Timeline

• First posted: 2006-04-11
• Last updated: 2009-06-23

Locations

3 sites across 1 country: Israel