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Anterior Cruciate Ligament ReconstructionPhase 3NMESNCT00737750

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

A Phase 3 study testing Kneehab and Poli-Stim in people with Anterior Cruciate Ligament Reconstruction, run by Bio-Medical Research, Ltd. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Kneehab and Poli-Stim
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteGermany
Study dates
Apr 2005to Oct 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • ATOS Clinic

    Heidelberg, Heidelberg, D-69115

Other trials in Germany

About this study

Official title: Phase III Study in Patients Undergoing Rehabilitation Post-Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)

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.

Read the 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.

Being tested
Kneehab, Poli-Stim, Control
Keywords
Neuromuscular electrical stimulation (NMES), Knee Surgery, Anterior cruciate ligament, Atrophy Prevention, Accelerated Recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KneehabDevice

    Also called Kneehab, neurotech

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

  • Poli-StimDevice

    Also called Poli-Stim, Neurotech

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

  • ControlBehavioural

    Voluntary quadriceps muscle contractions.

Study groups in NCT00737750
Study groupRoleWhat they receive
KHExperimentalKneehab is a garment integrated NMES device with multipath technology.
Receives: Device: Kneehab
PSActive comparatorPoli-Stim, a standard NMES device, used for 3 times per day, five days per week for 12 weeks.
Receives: Device: Poli-Stim
COActive comparatorControl group performed voluntary muscle contractions for 20 minutes 3 times per day, 5 days per week for 12 weeks.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks Intervention + Outcomes at 24 Weeks

Secondary outcomes (1)

  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).

    Measured: 12 weeks Intervention + Outcomes at 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2008 (estimated)
  2. Study startApr 2005
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00737750
Sponsor's protocol ID
BMR 04 2001A
Acronym
NMES
Status last verified
Aug 2008
First submitted
19 Aug 2008
Last updated
28 Aug 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 1997243

  • 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.

    PubMed 2347154

  • 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.

    PubMed 15730336

  • 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.

    PubMed 2929825

  • 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.

    PubMed 1894677

  • 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.

    PubMed 7726347

  • 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.

    PubMed 8467342

  • 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.

    PubMed 3258994

  • 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.

    PubMed 2293634

  • 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.

    PubMed 2034708

  • 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.

    PubMed 10063808

  • 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.

    PubMed 8407034

  • 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.

    PubMed 11665746

  • 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.

    PubMed 14524508

  • 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.

    PubMed 2108095

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Kneehab and Poli-Stim in people with Anterior Cruciate Ligament Reconstruction, run by Bio-Medical Research, Ltd. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 12 weeks Intervention + Outcomes at 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00737750, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2008.

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