A Phase 3 interventional study of Kneehab and Poli-Stim in Anterior Cruciate Ligament Reconstruction, sponsored by Bio-Medical Research, Ltd.. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-17.
Sponsored by Bio-Medical Research, Ltd. · Phase 3, Interventional, and Treatment
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.
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.
Bio-Medical Research, Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Kneehab is a garment integrated NMES device with multipath technology.
Device: Kneehab
Poli-Stim, a standard NMES device, used for 3 times per day, five days per week for 12 weeks.
Device: Poli-Stim
Control group performed voluntary muscle contractions for 20 minutes 3 times per day, 5 days per week for 12 weeks.
Behavioral: Control
Program of NMES 3 times per day, five days per week for 12 weeks.
Also known as: Kneehab K024258
Poli-Stim is standard NMES which the patients used for 20 minutes, 3 times per day, 5 days per week for 12 weeks.
Voluntary quadriceps muscle contractions.
Also known as: Voluntary muscle contractions
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
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
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Bio-Medical Research, Ltd.