Restoration of Knee Extension After ACL Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Physical Therapy, Ermi Knee Extensionater.
- Who it may be relevant to
- Registry conditions: Knee, ACL. Basic parameters: 14 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Restoration of Knee Extension After ACL Reconstruction: A Comparison of Standard Physical Therapy With and Without Adjunct Mechanical Stretching
Overview
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
- 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 minu
Primary outcome measures
- Changes in Knee Range of Motion [Time frame: Baseline, 2 weeks, 6 weeks, and 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07685561 · IRB-300016352 · ERMI LLC Device