KneePhase 1NCT07685561
Restoration of Knee Extension After ACL Reconstruction
A Phase 1 study testing Standard Physical Therapy and Ermi Knee Extensionater in people with Knee and ACL, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- What is being tested?
- Standard Physical Therapy and Ermi Knee Extensionater
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Mar 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14-65 yo
- Primary ACLR (BTB auto ONLY)
- Prior ACL tear treated non-op
Who cannot join
- Revision ACL surgery
- Major concomitant ligament reconstruction
- Neurologic lower-extremity disorder
- Inability to complete rehab
- Cognitive impairment preventing consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35243
Amit Momaya, MD, (205) 930-8494, amomaya@uabmc.edu
Camille Crane, (303) 652 - 7821,, camillecrane@uabmc.edu
About this study
Official title: Restoration of Knee Extension After ACL Reconstruction: A Comparison of Standard Physical Therapy With and Without Adjunct Mechanical Stretching
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.
- Being tested
- Standard Physical Therapy, Ermi Knee Extensionater
- Keywords
- ACL, Knee, knee reconstruction, Ermi Knee Extensionator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical TherapyBehavioural
Routine standard physical therapy for post op knee reconstructive surgery. May include use of knee Extensionator in a clinic setting.
Ermi Knee ExtensionaterDevice
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 group | Role | What they receive |
|---|---|---|
| Participants Receiving Standard of Care | Active comparator | 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). Receives: Behavioral: Standard Physical Therapy |
| Patient Receiving Ermi Knee Extensionator + Standard of Care | Experimental | 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. Receives: Behavioral: Standard Physical Therapy; Device: Ermi Knee Extensionater |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Knee Range of Motion
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.
Measured: Baseline, 2 weeks, 6 weeks, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KneeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Ermi LLC
- Responsible party
- Principal investigator, Amit Momaya, University of Alabama at Birmingham
- Investigators
- Amit Momaya, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685561
- Sponsor's protocol ID
- IRB-300016352
- Other IDs
- ERMI LLC Device
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Knee Extension After ACL Reconstruction: A Comparison of Standard Physical Therapy With and Without Adjunct Mechanical Stretching
- ClinicalTrials.gov ID
- NCT07685561
- Acronym / sponsor ID
- IRB-300016352
- Keywords
- ACL, Knee, knee reconstruction, Ermi Knee Extensionator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Ermi LLC
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Standard of Care | Active comparator | Behavioral: Standard Physical TherapyPatients 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). |
| Patient Receiving Ermi Knee Extensionator + Standard of Care | Experimental | Behavioral: Standard Physical Therapy, Device: Ermi Knee ExtensionaterPatients 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. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 14-65 yo
- Primary ACLR (BTB auto ONLY)
- Prior ACL tear treated non-op
Key exclusion criteria (5 listed)
- Revision ACL surgery
- Major concomitant ligament reconstruction
- Neurologic lower-extremity disorder
- Inability to complete rehab
- Cognitive impairment preventing consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Physical TherapyRoutine standard physical therapy for post op knee reconstructive surgery. May include use of knee Extensionator in a clinic setting. | Behavioural | Participants Receiving Standard of Care, Patient Receiving Ermi Knee Extensionator + Standard of Care |
| Ermi Knee ExtensionaterStandard 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. | Device | Patient Receiving Ermi Knee Extensionator + Standard of Care |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Momaya, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Standard Physical Therapy and Ermi Knee Extensionater in people with Knee and ACL, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Momaya, MD ((205) 930-8494, amomaya@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Knee Range of Motion (time frame: Baseline, 2 weeks, 6 weeks, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.