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

This study has been completed.
Sponsor:
Information provided by:
Bio-Medical Research, Ltd.
ClinicalTrials.gov Identifier:
NCT00737750
First received: August 19, 2008
Last updated: August 27, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Anterior Cruciate Ligament Reconstruction
Device: Kneehab
Device: Poli-Stim
Behavioral: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study in Patients Undergoing Rehabilitation Post-Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)

Resource links provided by NLM:


Further study details as provided by Bio-Medical Research, Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: April 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737750

Locations
Germany
ATOS Clinic
Heidelberg, Germany, D-69115
Sponsors and Collaborators
Bio-Medical Research, Ltd.
Investigators
Principal Investigator: Hans H Paessler, FRCSed Centre for Knee and Foot Surgery Sports Traumatology, ATOS Clinic, Heidelberg, Germany
  More Information

Publications:

Responsible Party: Prof. Hans H. Paessler, Centre for Knee and Foot Surgery, Sports Traumatology, ATOS Clinic
ClinicalTrials.gov Identifier: NCT00737750     History of Changes
Other Study ID Numbers: BMR 04 2001A
Study First Received: August 19, 2008
Last Updated: August 27, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Institutional Review Board

Keywords provided by Bio-Medical Research, Ltd.:
Neuromuscular electrical stimulation (NMES)
Knee Surgery
Anterior cruciate ligament
Atrophy Prevention
Accelerated Recovery

ClinicalTrials.gov processed this record on April 16, 2014