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

NCT00312793 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-06-23

No results posted yet for this study

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

DEVICE

stimulation of the quadriceps muscle with Myospare

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Meir Libergall, Prof. · Hadassah Medical Organization

  • Joseph Lowe, Dr. · Hadassah Medical Organization

  • Adi Fridman, Dr. · Hadassah Medical Organization

  • Naama Constantini, Dr. · Hadassah Medical Organization

  • Gabi Agar, Dr. · Asaf Ha'rofe Medical Organization

  • Yiftah Bar, Dr. · Asaf Ha'rofe Medical Organization

  • Gideon Man, Dr. · Meir Medical Organization

  • Yiftah Hetzroni, Dr. · Meir Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00312793 on ClinicalTrials.gov