Interventions to Enhance Quadriceps Output After ACLR

ConditionACL

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-40

SponsorUniversity of Wisconsin, Madison

About this trial

The investigators are interested in determining what treatments are effective in reducing inhibition after anterior cruciate ligament (ACL) surgery and helping people increase quadriceps strength. Two interventions that are often used clinically are neuromuscular electrical stimulation (NMES) and vibration. This is a study of how effective these treatments are, whether they work the same for everyone, and if one is better than the other. 22 participants will be enrolled and on study for 2 to 3 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have undergone ACLR within the previous 4 months

Are at least 2 months post-ACLR

Disqualifiers

A history of ACLR on both legs

secondary lower extremity surgery

leg or foot fracture

Unable to walk without an assistive device

Trial design

Design model

Crossover

Treatments tested in this trial

NMES
Device
The thigh of the surgical leg will be cleaned with isopropyl alcohol. 2.75" x 5" NMES electrodes (Dura-Stick Plus, Chattanooga, DJO Global, Dallas, TX) will be adhered to the proximal and distal aspects of the quadriceps muscles. An FDA-approved portable neuromuscular electrical stimulator (Empi Continuum, DJO Global, Dallas, TX) will be utilized to deliver a biphasic square wave pulse (frequency 75 Hz, pulse width 300 µs) to the quadriceps of the surgical limb. Participants will control both the amplitude of current delivered (0-100 mA) and the on/off timing of the stimulation via a wired control switch. Participants will complete common post-ACLR rehabilitation exercises while NMES is delivered (total time for exercises is approximately 20 minutes).
Vibration
Device
Participants will sit in a comfortable position on a treatment plinth with knees flexed to \~30°, hips flexed between 30-60°, and the back supported. The back of the thighs will rest on the vibration pads of a commercial vibration device (Thumper Versa Pro Massager, (Thumper Massager Inc., Markham, Ontario, CA). Participants will sit at rest for 20 minutes while the vibration device provides a 30 Hz vibration with an amplitude of \~6 mm.

Treatment groups

22 Participants

are divided into 2 treatment groups

Group A: NMES then VibrationExperimental treatment 2 interventions

Group B: Vibration then NMESExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Change in knee extensor peak torque production

Time frame

measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks

Secondary outcomes

Change in knee extensor torque steadiness

Time frame

measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov

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