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Completed

NCT Number: NCT00738010

Effectiveness of Kneehab in Strengthening Quadriceps in Rehabilitation Post Anterior Cruciate Ligament (ACL) Reconstruction

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 NMES with multipath activation 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 and the time to complete 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 without use of a walking aid. A comparison between the groups of the time for return to usual work activities was planned.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ATOS Clinic

Heidelberg, D-69115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kneehab

Device

Program of NMES 3 times per day, five days per week for 12 weeks.

Other names: Kneehab K024258

Poli-Stim

Device

Poli-Stim is standard NMES which the patients used for 20 minutes, 3 times per day, 5 days per week for 12 weeks.

Control

Behavioral

Voluntary quadriceps muscle contractions.

Other names: Voluntary muscle contractions

Primary outcomes

  1. 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

Secondary outcomes

  1. Strength test of flexors of the knee joint and 5 tests of coordination and proprioception (triple hop; side-step; carioca; timed hop and cross-over hop).

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bio-Medical Research, Ltd.

Industry

Registry information

Official study title

The Effectiveness of Kneehab in Strengthening the Quadriceps of Patients in Rehabilitation After Anterior Cruciate Ligament Reconstruction

Acronym: NMES

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 20, 2008
Registry last updated
Sep 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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