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

NCT00738010 | Completed Phase 3

• 1 other identifier: BMR 04 2001
• 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 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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

NMES; ACL; Atrophy Prevention; Accelerated Recovery; Knee Surgery

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

Secondary Outcomes (1)

• 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).

  12 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 K024258

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.

PS

Control BEHAVIORAL

Voluntary quadriceps muscle contractions.

Also known as: Voluntary 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

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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: September 17, 2008

Record last verified: 2008-09

Locations

DE (1)