Clinical trial NCT00738010: Effectiveness of Kneehab in Strengthening Quadriceps in Rehabilitation Post Anterior Cruciate Ligament (ACL) Reconstruction
Official title: The Effectiveness of Kneehab in Strengthening the Quadriceps of Patients in Rehabilitation After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: NMES
ACL
Atrophy Prevention
Accelerated Recovery
Knee Surgery
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 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.

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
Secondary outcomes:
measure: 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).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: ATOS Clinic
Study officials:
References:
citation: Andersson C, Odensten M, Gillquist J. Knee function after surgical or nonsurgical treatment of acute rupture of the anterior cruciate ligament: a randomized study with a long-term follow-up period. Clin Orthop Relat Res. 1991 Mar;(264):255-63.
citation: Barber SD, Noyes FR, Mangine RE, McCloskey JW, Hartman W. Quantitative assessment of functional limitations in normal and anterior cruciate ligament-deficient knees. Clin Orthop Relat Res. 1990 Jun;(255):204-14.
citation: Bax L, Staes F, Verhagen A. Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials. Sports Med. 2005;35(3):191-212. doi: 10.2165/00007256-200535030-00002.
citation: Paillard T, Noe F, Passelergue P, Dupui P. Electrical stimulation superimposed onto voluntary muscular contraction. Sports Med. 2005;35(11):951-66. doi: 10.2165/00007256-200535110-00003.
citation: Snyder-Mackler L, Ladin Z, Schepsis AA, Young JC. Electrical stimulation of the thigh muscles after reconstruction of the anterior cruciate ligament. Effects of electrically elicited contraction of the quadriceps femoris and hamstring muscles on gait and on strength of the thigh muscles. J Bone Joint Surg Am. 1991 Aug;73(7):1025-36.
citation: Snyder-Mackler L, Delitto A, Bailey SL, Stralka SW. Strength of the quadriceps femoris muscle and functional recovery after reconstruction of the anterior cruciate ligament. A prospective, randomized clinical trial of electrical stimulation. J Bone Joint Surg Am. 1995 Aug;77(8):1166-73. doi: 10.2106/00004623-199508000-00004.
citation: Paessler HH, Mastrokalos DS. Anterior cruciate ligament reconstruction using semitendinosus and gracilis tendons, bone patellar tendon, or quadriceps tendon-graft with press-fit fixation without hardware. A new and innovative procedure. Orthop Clin North Am. 2003 Jan;34(1):49-64. doi: 10.1016/s0030-5898(02)00070-6.
citation: Barrett DS. Proprioception and function after anterior cruciate reconstruction. J Bone Joint Surg Br. 1991 Sep;73(5):833-7. doi: 10.1302/0301-620X.73B5.1894677.
citation: Beynnon BD, Fleming BC, Johnson RJ, Nichols CE, Renstrom PA, Pope MH. Anterior cruciate ligament strain behavior during rehabilitation exercises in vivo. Am J Sports Med. 1995 Jan-Feb;23(1):24-34. doi: 10.1177/036354659502300105.
citation: Currier DP, Ray JM, Nyland J, Rooney JG, Noteboom JT, Kellogg R. Effects of electrical and electromagnetic stimulation after anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 1993 Apr;17(4):177-84. doi: 10.2519/jospt.1993.17.4.177.
citation: Delitto A, Rose SJ, McKowen JM, Lehman RC, Thomas JA, Shively RA. Electrical stimulation versus voluntary exercise in strengthening thigh musculature after anterior cruciate ligament surgery. Phys Ther. 1988 May;68(5):660-3. doi: 10.1093/ptj/68.5.660.
citation: Paillard T. Combined application of neuromuscular electrical stimulation and voluntary muscular contractions. Sports Med. 2008;38(2):161-77. doi: 10.2165/00007256-200838020-00005.
citation: Draganich LF, Vahey JW. An in vitro study of anterior cruciate ligament strain induced by quadriceps and hamstrings forces. J Orthop Res. 1990 Jan;8(1):57-63. doi: 10.1002/jor.1100080107.
citation: Draper V, Ballard L. Electrical stimulation versus electromyographic biofeedback in the recovery of quadriceps femoris muscle function following anterior cruciate ligament surgery. Phys Ther. 1991 Jun;71(6):455-61; discussion 461-4. doi: 10.1093/ptj/71.6.455.
citation: Eastlack ME, Axe MJ, Snyder-Mackler L. Laxity, instability, and functional outcome after ACL injury: copers versus noncopers. Med Sci Sports Exerc. 1999 Feb;31(2):210-5. doi: 10.1097/00005768-199902000-00002.
citation: Engstrom B, Gornitzka J, Johansson C, Wredmark T. Knee function after anterior cruciate ligament ruptures treated conservatively. Int Orthop. 1993;17(4):208-13. doi: 10.1007/BF00194180.
citation: Fitzgerald GK, Lephart SM, Hwang JH, Wainner RS. Hop tests as predictors of dynamic knee stability. J Orthop Sports Phys Ther. 2001 Oct;31(10):588-97. doi: 10.2519/jospt.2001.31.10.588.
citation: Fitzgerald GK, Piva SR, Irrgang JJ. A modified neuromuscular electrical stimulation protocol for quadriceps strength training following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 2003 Sep;33(9):492-501. doi: 10.2519/jospt.2003.33.9.492.
citation: Havlik E, Haber P, Klein G, Roggla G, Bergmann H. Increased 137caesium whole body radioactivity in high-performance athletes. Int J Sports Med. 1990 Feb;11(1):37-40. doi: 10.1055/s-2007-1024759.
citation: Gobbi A, Tuy B, Mahajan S, Panuncialman I. Quadrupled bone-semitendinosus anterior cruciate ligament reconstruction: a clinical investigation in a group of athletes. Arthroscopy. 2003 Sep;19(7):691-9. doi: 10.1016/s0749-8063(03)00685-6.
citation: Hefti F, Muller W, Jakob RP, Staubli HU. Evaluation of knee ligament injuries with the IKDC form. Knee Surg Sports Traumatol Arthrosc. 1993;1(3-4):226-34. doi: 10.1007/BF01560215.
citation: Hehl G, Hoellen I, Wissmeyer T, Ziegler U. [Isokinetic muscle training with high motion speeds in the rehabilitation following surgical treatment of fresh anterior cruciate rupture]. Z Orthop Ihre Grenzgeb. 1995 Jul-Aug;133(4):306-10. doi: 10.1055/s-2008-1039797. German.
citation: Jarvela T, Kannus P, Latvala K, Jarvinen M. Simple measurements in assessing muscle performance after an ACL reconstruction. Int J Sports Med. 2002 Apr;23(3):196-201. doi: 10.1055/s-2002-23171.
citation: Keays SL, Bullock-Saxton J, Keays AC, Newcombe P. Muscle strength and function before and after anterior cruciate ligament reconstruction using semitendonosus and gracilis. Knee. 2001 Oct;8(3):229-34. doi: 10.1016/s0968-0160(01)00099-0.
citation: Keays SL, Bullock-Saxton JE, Newcombe P, Keays AC. The relationship between knee strength and functional stability before and after anterior cruciate ligament reconstruction. J Orthop Res. 2003 Mar;21(2):231-7. doi: 10.1016/S0736-0266(02)00160-2.
citation: Schiaffino S, Sjostrom M, Thornell LE, Nystrom B, Hackelius L. The process of survival of denervated and freely autotransplantated skeletal muscle. Experientia. 1975 Nov 15;31(11):1328-30. doi: 10.1007/BF01945810.
citation: Lieber RL, Silva PD, Daniel DM. Equal effectiveness of electrical and volitional strength training for quadriceps femoris muscles after anterior cruciate ligament surgery. J Orthop Res. 1996 Jan;14(1):131-8. doi: 10.1002/jor.1100140121.
citation: Morrissey MC, Hooper DM, Drechsler WI, Hill HJ, Bucknill T. Velocity specificity in early training of the knee extensors after anterior cruciate ligament reconstruction. Eur J Appl Physiol. 2000 Apr;81(6):493-6. doi: 10.1007/s004210050073.
citation: Morrissey MC, Brewster CE, Shields CL Jr, Brown M. The effects of electrical stimulation on the quadriceps during postoperative knee immobilization. Am J Sports Med. 1985 Jan-Feb;13(1):40-5. doi: 10.1177/036354658501300107.
citation: Noyes FR, Mooar PA, Matthews DS, Butler DL. The symptomatic anterior cruciate-deficient knee. Part I: the long-term functional disability in athletically active individuals. J Bone Joint Surg Am. 1983 Feb;65(2):154-62. doi: 10.2106/00004623-198365020-00003. No abstract available.
citation: Noyes FR, Matthews DS, Mooar PA, Grood ES. The symptomatic anterior cruciate-deficient knee. Part II: the results of rehabilitation, activity modification, and counseling on functional disability. J Bone Joint Surg Am. 1983 Feb;65(2):163-74. doi: 10.2106/00004623-198365020-00004. No abstract available.
citation: Nyland J, Caborn DN, Rothbauer J, Kocabey Y, Couch J. Two-year outcomes following ACL reconstruction with allograft tibialis anterior tendons: a retrospective study. Knee Surg Sports Traumatol Arthrosc. 2003 Jul;11(4):212-8. doi: 10.1007/s00167-003-0371-x. Epub 2003 Jun 19.
citation: Oshimo TA, Greene TA, Jensen GM, Lopopolo RB. The effect of varied hip angles on the generation of internal tibial rotary torque. Med Sci Sports Exerc. 1983;15(6):529-34.
citation: Parker MG, Bennett MJ, Hieb MA, Hollar AC, Roe AA. Strength response in human femoris muscle during 2 neuromuscular electrical stimulation programs. J Orthop Sports Phys Ther. 2003 Dec;33(12):719-26. doi: 10.2519/jospt.2003.33.12.719.
citation: Petschnig R, Baron R, Albrecht M. The relationship between isokinetic quadriceps strength test and hop tests for distance and one-legged vertical jump test following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 1998 Jul;28(1):23-31. doi: 10.2519/jospt.1998.28.1.23.
citation: Renstrom P, Arms SW, Stanwyck TS, Johnson RJ, Pope MH. Strain within the anterior cruciate ligament during hamstring and quadriceps activity. Am J Sports Med. 1986 Jan-Feb;14(1):83-7. doi: 10.1177/036354658601400114.
citation: Rudolph KS, Axe MJ, Snyder-Mackler L. Dynamic stability after ACL injury: who can hop? Knee Surg Sports Traumatol Arthrosc. 2000;8(5):262-9. doi: 10.1007/s001670000130.
citation: Segawa H, Omori G, Koga Y, Kameo T, Iida S, Tanaka M. Rotational muscle strength of the limb after anterior cruciate ligament reconstruction using semitendinosus and gracilis tendon. Arthroscopy. 2002 Feb;18(2):177-82. doi: 10.1053/jars.2002.29894.
citation: Sekiya I, Muneta T, Ogiuchi T, Yagishita K, Yamamoto H. Significance of the single-legged hop test to the anterior cruciate ligament-reconstructed knee in relation to muscle strength and anterior laxity. Am J Sports Med. 1998 May-Jun;26(3):384-8. doi: 10.1177/03635465980260030701.
citation: Shelburne KB, Pandy MG. A musculoskeletal model of the knee for evaluating ligament forces during isometric contractions. J Biomech. 1997 Feb;30(2):163-76. doi: 10.1016/s0021-9290(96)00119-4.
citation: Loosli AR. Portable versus home stimulators. Phys Ther. 1995 Mar;75(3):237-8. doi: 10.1093/ptj/75.3.237. No abstract available.
citation: Vanderthommen M, Crielaard JM. [Muscle electric stimulation in sports medicine]. Rev Med Liege. 2001 May;56(5):391-5. French.
citation: Viola RW, Sterett WI, Newfield D, Steadman JR, Torry MR. Internal and external tibial rotation strength after anterior cruciate ligament reconstruction using ipsilateral semitendinosus and gracilis tendon autografts. Am J Sports Med. 2000 Jul-Aug;28(4):552-5. doi: 10.1177/03635465000280041801.