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NCT Number: NCT07685561

Restoration of Knee Extension After ACL Reconstruction

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.

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Key information

Conditions

Knee ACL

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location contact

Amit Momaya, MD

CONTACT

[email protected]

(205) 930-8494

Amit Momaya, MD

PRINCIPAL_INVESTIGATOR

Camille Crane

CONTACT

[email protected]

(303) 652 - 7821,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 14-65 yo
  • Primary ACLR (BTB auto ONLY)
  • Prior ACL tear treated non-op

Exclusion criteria

  • Revision ACL surgery
  • Major concomitant ligament reconstruction
  • Neurologic lower-extremity disorder
  • Inability to complete rehab
  • Cognitive impairment preventing consent

Treatment and study plan

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.

Primary outcomes

  1. Changes in Knee Range of Motion

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Momaya, MD

CONTACT

[email protected]

(205) 930-8494

Camille Crane

CONTACT

[email protected]

303-652-7821

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Ermi LLC

Registry information

Official study title

Restoration of Knee Extension After ACL Reconstruction: A Comparison of Standard Physical Therapy With and Without Adjunct Mechanical Stretching

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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