Effectiveness of Kneehab in Strengthening the Quadriceps of Patients Post Anterior Cruciate Ligament (ACL) Reconstruction (NMES)

August 27, 2008 updated by: Bio-Medical Research, Ltd.

Phase III Study in Patients Undergoing Rehabilitation Post-Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)

Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to one of three groups. Group Group KH (Kneehab n=33)trained with a new type of garment integrated NMES for 20 minutes, 3 times per day, 5 days per week for 12 weeks; Group PS (Poli-Stim n=29) trained with standard neuromuscular electrical stimulation (NMES) for 20 minutes per day, 5 days per week for 12 weeks; Group CO (Control - n=34), which did not use muscle stimulation, performed voluntary isometric quadriceps muscle contractions. Patients receiving either form of NMES treatment were instructed to isometrically contract the quadriceps muscle voluntarily with each electrical muscle stimulation. All three groups superimposed this training schedule on the standard post-ACL reconstruction rehabilitation protocol used at the clinic.

The study design corresponded to a two-way variance analysis with three groups and 4 examination times (Baseline, 6 weeks, 12 weeks and 24 weeks post ACL reconstruction). The level of significance was set at 5%. The key indicators of the quadriceps muscle training intervention were the isokinetic strength development of the extensors of the injured leg at 90 degrees/second and 180 degrees/second and the distance achieved by participants performing the single-leg hop, the shuttle run. The target was to show a difference of 10% in the relative distance jumped for the single-leg hop and for the isokinetic strength tests and a 1.2 second difference in the time to complete the shuttle run. The target of 3 weeks was set for participants to achieve full weight-bearing capability with use of a walking aid. A comparison between the groups of the time for return to usual work activities was planned.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 garment-integrated NMES to a standard post-surgery rehabilitation program. In both cases the NMES was superimposed on isometric voluntary muscle contractions.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, D-69115
        • ATOS Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KH
Kneehab is a garment integrated NMES device with multipath technology.
Device: Kneehab
Program of NMES 3 times per day, five days per week for 12 weeks.
Other Names:
  • Kneehab, neurotech
Active Comparator: PS
Poli-Stim, a standard NMES device, used for 3 times per day, five days per week for 12 weeks.
Device: Poli-Stim
Poli-Stim is standard NMES which the patients used for 20 minutes, 3 times per day, 5 days per week for 12 weeks.
Other Names:
  • Poli-Stim, Neurotech
Active Comparator: CO
Control group performed voluntary muscle contractions for 20 minutes 3 times per day, 5 days per week for 12 weeks.
Behavioral: Control
Voluntary quadriceps muscle contractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Isokinetic strength test of extension of the injured leg. Relative strength extension ratio (injured/uninjured). Distance of the jump achieved in the single leg hop and the time to achieve the shuttle run.
Time Frame: 12 weeks Intervention + Outcomes at 24 Weeks
12 weeks Intervention + Outcomes at 24 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Strength test of flexors of the knee joint and 5 tests of coordination of proprioceptions (triple hop; side-step; carioca; timed hop and cross-over hop).
Time Frame: 12 weeks Intervention + Outcomes at 24 weeks
12 weeks Intervention + Outcomes at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio-Medical Research, Ltd.

Investigators

  • Principal Investigator: Hans H Paessler, FRCSed, Centre for Knee and Foot Surgery Sports Traumatology, ATOS Clinic, Heidelberg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 28, 2008

Last Update Submitted That Met QC Criteria

August 27, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BMR 04 2001A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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