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Sponsored by: |
Bio-Medical Research, Ltd. |
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Information provided by: | Bio-Medical Research, Ltd. |
ClinicalTrials.gov Identifier: | NCT00738010 |
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.
Condition | Intervention | Phase |
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Anterior Cruciate Ligament Reconstruction |
Device: Kneehab Device: Poli-Stim Behavioral: Control |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Effectiveness of Kneehab in Strengthening the Quadriceps of Patients in Rehabilitation After Anterior Cruciate Ligament Reconstruction |
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 |
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KH: Experimental
Kneehab is a garment integrated NMES device with multipath technology.
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Device: Kneehab
Program of NMES 3 times per day, five days per week for 12 weeks.
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PS: Active Comparator
Poli-Stim, a standard NMES device, used for 3 times per day, five days per week for 12 weeks.
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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.
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CO: Active Comparator
Control group performed voluntary muscle contractions for 20 minutes 3 times per day, 5 days per week for 12 weeks.
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Behavioral: Control
Voluntary quadriceps muscle contractions.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Atos Clinic ( Dr. Hans Paessler ) |
Study ID Numbers: | BMR 04 2001 |
Study First Received: | August 19, 2008 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00738010 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
NMES ACL Atrophy Prevention Accelerated Recovery Knee Surgery |
Atrophy |