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Can a simple cuff boost leg injury recovery? new study aims to find out.

NCT ID NCT04149977

Symptom relief Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a pressure cuff that partially blocks blood flow during physical therapy can help people with leg tendon or bone injuries regain strength and muscle mass. About 128 adults aged 18 to 65 with specific leg injuries will be randomly assigned to either a real or a low-pressure placebo cuff during 6 weeks of therapy. The goal is to see if this simple technique speeds up recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Physical therapy with a pressure cuff that partially restricts blood flow
What this could lead to
If it works, this could offer a way to speed up recovery from certain leg injuries using a simple, non-drug method.
What could go wrong
This is a small, early-stage study with only 128 participants, so results may not apply to everyone. The cuff may cause discomfort or not provide extra benefit over standard therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be at least 18 years of age and younger than 65 years of age * ASA class I-II * Diagnosed with a lower limb extensor injury (quadriceps tendon rupture, patella tendon rupture, patella fracture) * Intention to receive physical therapy as standard of care Exclusion Criteria: * Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.) * Younger than 18 years of age or older than 65 * Any patient considered a vulnerable subject * Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension * Concomitant lower extremity traumatic injuries, delaying or precluding the subject's ability to participate in the therapy * Immobile or use of mobile assistive device prior to injury * No prior extensor injuries * Patients with Sickle cell anemia or venous thromboembolism * Patients with cancer or Lymphectomies * Patients with increased intracranial pressure * Patients with intention to receive standard therapy and not the study therapy

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Conditions

The condition(s) this trial relates to.

Leg Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lower limb injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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