Clinical trial NCT00737750: Effectiveness of Kneehab in Strengthening the Quadriceps of Patients Post Anterior Cruciate Ligament (ACL) Reconstruction
Official title: Phase III Study in Patients Undergoing Rehabilitation Post-Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Neuromuscular electrical stimulation (NMES)
Knee Surgery
Anterior cruciate ligament
Atrophy Prevention
Accelerated Recovery
Lead sponsor: Bio-Medical Research, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks Intervention + Outcomes at 24 Weeks
Secondary outcomes:
measure: 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).
timeFrame: 12 weeks Intervention + Outcomes at 24 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: ATOS Clinic
Study officials:
affiliation: Centre for Knee and Foot Surgery Sports Traumatology, ATOS Clinic, Heidelberg, Germany
name: Hans H Paessler, FRCSed
role: PRINCIPAL_INVESTIGATOR
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