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NOT YET RECRUITING
NCT07685561
PHASE1

Restoration of Knee Extension After ACL Reconstruction

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

14 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2026-12

Completion Date

2032-03

Last Updated

2026-10-15

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Standard Physical Therapy

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

DEVICE

Ermi 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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States