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Restoration of Knee Extension After ACL Reconstruction

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07685561
Enrollment
58
Registered
2026-07-06
Start date
2026-08-01
Completion date
2032-03-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL, Knee

Keywords

ACL, Knee, knee reconstruction, Ermi Knee Extensionator

Brief summary

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.

Interventions

BEHAVIORALStandard Physical Therapy

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

DEVICEErmi Knee Extensionater

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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
Ermi LLC
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Knee Range of MotionBaseline, 2 weeks, 6 weeks, and 3 monthsA 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.

Countries

United States

Contacts

CONTACTAmit Momaya, MD
amomaya@uabmc.edu(205) 930-8494
CONTACTCamille Crane
camillecrane@uabmc.edu303-652-7821
PRINCIPAL_INVESTIGATORAmit Momaya, MD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026