Restoration of Knee Extension After ACL Reconstruction

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07685561
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • ACL
  • Knee

Eligibility Criteria

Sex
ALL
Age
14 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2032
Completion
Mar 31, 2032

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Participants Receiving Standard of Care
    Patients will receive standard physical therapy alone: postoperative rehabilitation as per the treating clinician's standard ACL protocol (this may include use of the Knee Extensionater in a clinical setting).
  • Experimental: Patient Receiving Ermi Knee Extensionator + Standard of Care
    Patients will receive the Ermi Knee Extensionater plus standard physical therapy: Standard rehabilitation protocol plus daily home use of the Knee Extensionater for terminal extension stretching.

Primary Outcome Measure

Changes in Knee Range of Motion [ Time Frame: Baseline, 2 weeks, 6 weeks, and 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35243
Amit Momaya, MD
[email protected]
(205) 930-8494
Camille Crane
[email protected]
(303) 652 - 7821,
Amit Momaya, MD (PRINCIPAL_INVESTIGATOR)

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