Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-02 @ 9:49 AM
Study NCT ID:
NCT00312793
Status:
TERMINATED
Last Update Posted:
2009-06-23
First Post:
2006-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study stopped becaust the sponsor did not wish to proceede with the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: