Effectiveness of Kneehab in Strengthening the Quadriceps of Patients Post Anterior Cruciate Ligament (ACL) Reconstruction (NMES)
|ClinicalTrials.gov Identifier: NCT00737750|
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : August 28, 2008
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 or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Reconstruction||Device: Kneehab Device: Poli-Stim Behavioral: Control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Phase III Study in Patients Undergoing Rehabilitation Post-Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
Kneehab is a garment integrated NMES device with multipath technology.
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.
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.
Voluntary quadriceps 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 Intervention + Outcomes at 24 Weeks ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737750
|Heidelberg, Germany, D-69115|
|Principal Investigator:||Hans H Paessler, FRCSed||Centre for Knee and Foot Surgery Sports Traumatology, ATOS Clinic, Heidelberg, Germany|