Status:
COMPLETED
Effectiveness of Kneehab in Strengthening the Quadriceps of Patients Post Anterior Cruciate Ligament (ACL) Reconstruction
Lead Sponsor:
Bio-Medical Research, Ltd.
Conditions:
Anterior Cruciate Ligament Reconstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to one of three gr...
Detailed Description
Single center, prospective, controlled, randomized, single blind study in 96 patients following anterior crucial ligament (ACL)reconstruction to compare the effect of adding traditional NMES or garmen...
Eligibility Criteria
Inclusion
- Persons who had surgical reconstruction of the anterior cruciate ligament
- Persons with additional treatment of minor miniscal defects
- Persons who were willing and able to provide Informed Consent
Exclusion
- Persons who had multi-ligament reconstruction
- ACL patients with a microfracture or extra burden on the knee
- Persons who registered pain above level 3 on the IKDC subjective evaluation pain scale questions, 3 days after surgery
- Participants in a volunteer study within the previous ninety (90) days
- Persons with serious cardiac arrhythmias or other implanted devices
- Persons with cardiac pacemakers
- Persons with neurological or psychiatric disorders
- Persons who are pregnant or breastfeeding
- Intake of drugs that interfere with the neuromuscular system
- Persons with epilepsy
- Any condition or history which in the opinion of the Principal Investigator might increase the risk to an individual or interfere with the evaluation of data
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00737750
Start Date
April 1 2005
End Date
October 1 2006
Last Update
August 28 2008
Active Locations (1)
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1
ATOS Clinic
Heidelberg, Heidelberg, Germany, D-69115