Effectiveness of Kneehab in Strengthening the Quadriceps of Patients Post Anterior Cruciate Ligament (ACL) Reconstruction

NCT00737750 | Completed Phase 3

• 1 other identifier: BMR 04 2001A
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Neuromuscular electrical stimulation (NMES); Knee Surgery; Anterior cruciate ligament; Atrophy Prevention; Accelerated Recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks Intervention + Outcomes at 24 Weeks

Secondary Outcomes (1)

• 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).

  12 weeks Intervention + Outcomes at 24 weeks

Study Arms (3)

KH

EXPERIMENTAL

Kneehab is a garment integrated NMES device with multipath technology.

Device: Kneehab

PS

ACTIVE COMPARATOR

Poli-Stim, a standard NMES device, used for 3 times per day, five days per week for 12 weeks.

Device: Poli-Stim

CO

ACTIVE COMPARATOR

Control group performed voluntary muscle contractions for 20 minutes 3 times per day, 5 days per week for 12 weeks.

Behavioral: Control

Interventions

Kneehab DEVICE

Program of NMES 3 times per day, five days per week for 12 weeks.

Also known as: Kneehab, neurotech

KH

Poli-Stim DEVICE

Poli-Stim is standard NMES which the patients used for 20 minutes, 3 times per day, 5 days per week for 12 weeks.

Also known as: Poli-Stim, Neurotech

PS

Control BEHAVIORAL

Voluntary quadriceps muscle contractions.

CO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio-Medical Research, Ltd.: lead

Study Sites (1)

ATOS Clinic

Heidelberg, Heidelberg, D-69115, Germany

Location

Related Publications (47)

• 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.

  PMID: 1997243 BACKGROUND

• 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.

  PMID: 2347154 BACKGROUND

• 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.

  PMID: 15730336 BACKGROUND

• Barrack RL, Skinner HB, Buckley SL. Proprioception in the anterior cruciate deficient knee. Am J Sports Med. 1989 Jan-Feb;17(1):1-6. doi: 10.1177/036354658901700101.

  PMID: 2929825 BACKGROUND

• 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.

  PMID: 1894677 BACKGROUND

• 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.

  PMID: 7726347 BACKGROUND

• 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.

  PMID: 8467342 BACKGROUND

• 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.

  PMID: 3258994 BACKGROUND

• 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.

  PMID: 2293634 BACKGROUND

• 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.

  PMID: 2034708 BACKGROUND

• 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.

  PMID: 10063808 BACKGROUND

• 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.

  PMID: 8407034 BACKGROUND

• 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.

  PMID: 11665746 BACKGROUND

• 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.

  PMID: 14524508 BACKGROUND

• 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.

  PMID: 2108095 BACKGROUND

• 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.

  PMID: 12966375 BACKGROUND

• 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.

  PMID: 8536037 BACKGROUND

• 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.

  PMID: 7571796 BACKGROUND

• 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.

  PMID: 11914983 BACKGROUND

• 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.

  PMID: 11706731 BACKGROUND

• 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.

  PMID: 12568953 BACKGROUND

• Kramer J, Nusca D, Fowler P, Webster-Bogaert S. Knee flexor and extensor strength during concentric and eccentric muscle actions after anterior cruciate ligament reconstruction using the semitendinosus tendon and ligament augmentation device. Am J Sports Med. 1993 Mar-Apr;21(2):285-91. doi: 10.1177/036354659302100220.

  PMID: 8465926 BACKGROUND

• Kvist J, Karlberg C, Gerdle B, Gillquist J. Anterior tibial translation during different isokinetic quadriceps torque in anterior cruciate ligament deficient and nonimpaired individuals. J Orthop Sports Phys Ther. 2001 Jan;31(1):4-15. doi: 10.2519/jospt.2001.31.1.4.

  PMID: 11204794 BACKGROUND

• 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.

  PMID: 8618155 BACKGROUND

• Chow GK, Streem SB. Extracorporeal lithotripsy. Update on technology. Urol Clin North Am. 2000 May;27(2):315-22. doi: 10.1016/s0094-0143(05)70260-3.

  PMID: 10778473 BACKGROUND

• 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.

  PMID: 3872083 BACKGROUND

• 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.

  PMID: 6687391 BACKGROUND

• 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.

  PMID: 6822580 BACKGROUND

• 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.

  PMID: 12827225 BACKGROUND

• 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.

  PMID: 6656564 BACKGROUND

• 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.

  PMID: 14743985 BACKGROUND

• 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.

  PMID: 12735201 BACKGROUND

• 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.

  PMID: 18201117 BACKGROUND

• 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.

  PMID: 16271009 BACKGROUND

• 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.

  PMID: 9653687 BACKGROUND

• 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.

  PMID: 3752352 BACKGROUND

• 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.

  PMID: 11061293 BACKGROUND

• 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.

  PMID: 11830812 BACKGROUND

• 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.

  PMID: 9617400 BACKGROUND

• 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.

  PMID: 9001937 BACKGROUND

• 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.

  PMID: 1874764 BACKGROUND

• 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.

  PMID: 7642660 BACKGROUND

• Stevens JE, Mizner RL, Snyder-Mackler L. Neuromuscular electrical stimulation for quadriceps muscle strengthening after bilateral total knee arthroplasty: a case series. J Orthop Sports Phys Ther. 2004 Jan;34(1):21-9. doi: 10.2519/jospt.2004.34.1.21.

  PMID: 14964588 BACKGROUND

• Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.

  PMID: 4028566 BACKGROUND

• Vanderthommen M, Crielaard JM. [Muscle electric stimulation in sports medicine]. Rev Med Liege. 2001 May;56(5):391-5. French.

  PMID: 11475938 BACKGROUND

• 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.

  PMID: 10921649 BACKGROUND

• Wilk KE, Romaniello WT, Soscia SM, Arrigo CA, Andrews JR. The relationship between subjective knee scores, isokinetic testing, and functional testing in the ACL-reconstructed knee. J Orthop Sports Phys Ther. 1994 Aug;20(2):60-73. doi: 10.2519/jospt.1994.20.2.60.

  PMID: 7920603 BACKGROUND

Study Officials

• Hans H Paessler, FRCSed

  Centre for Knee and Foot Surgery Sports Traumatology, ATOS Clinic, Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 20, 2008
• Study Start: April 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: August 28, 2008

Record last verified: 2008-08

Locations

DE (1)