Health TrialsbyHealthPanel

Restoration of Knee Extension After ACL Reconstruction

ConditionsKneeACL
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age14-65
SponsorUniversity of Alabama at Birmingham

About this trial

The purpose of this study is to determine whether the addition of a home-based high-intensity knee extension stretching device (Ermi Knee Extensionater) to standard postoperative physical therapy improves recovery of full knee extension following ACL reconstruction compared with standard physical therapy alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 14-65 yo

Primary ACLR (BTB auto ONLY)

Prior ACL tear treated non-op

Disqualifiers

Revision ACL surgery

Major concomitant ligament reconstruction

Neurologic lower-extremity disorder

Inability to complete rehab

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Physical Therapy

    Behavioral

    Routine standard physical therapy for post op knee reconstructive surgery. May include use of knee Extensionator in a clinic setting.

  • Ermi Knee Extensionater

    Device

    Standard rehabilitation protocol plus daily home use of the Knee Extensionater for terminal extension stretching. The Ermi device will be distributed to all participants in Arm 2 preoperatively. Stretching protocols will be provided at this time. Following surgery, participants must complete daily home stretching sessions (60 total minutes of end-range stretching per day) starting at postoperative day one. Each stretching session is broken down into 10 minutes of stretching, followed by 10 minutes of rest. This is repeated throughout the day until a total of 60 minutes of stretching is completed. There should be at least one hour between sessions. Stretching sessions will continue until 3 months postop.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Participants Receiving Standard of CareActive comparator 1 intervention
Group B: Patient Receiving Ermi Knee Extensionator + Standard of CareExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Changes in Knee Range of Motion

A goniometer will be used to measure the post operative knee's range of motion an angle or to rotate an object to a precise angular position.

Time frame
Baseline, 2 weeks, 6 weeks, and 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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

University of Alabama at Birmingham

Lead sponsor

Ermi LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: