Lower Limb InjuryNCT04149977
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
A study testing Physical Therapy with pressure cuff in people with Lower Limb Injury, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Injury
- What is being tested?
- Physical Therapy with pressure cuff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Jun 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
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, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Dhruv Shankar, 240-848-8645, dhruv.shankar@nyulangone.org
Guillem Gonzalez-Lomas, MD
About this study
Official title: Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study
The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.
Read the detailed description
The purpose is to restrict venous outflow with an inflatable cuff to create a high intensity environment increases muscle hypertrophy, thus promoting a more efficient form of rehabilitation. Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff. The cuff is placed around the desired limb before a specific exercise, the physical therapist determines the appropriate pressure and time, and the patient completes the exercise as they normally would. The monitor determines the limb occlusion pressure and has an automatic timer that will deflate after the specified time has elapsed. There are also audio and visual alarms that alert the user of under or over pressurization. The specific pressure will vary based on patient's tolerance and will stay consistent through each exercise. Thus far blood flow restriction therapy has been tested in patients with several pathologies but there is limited literature on its effect on lower limb extensor injuries.
- Conditions
- Lower Limb Injury
- Being tested
- Physical Therapy with pressure cuff, Physical Therapy with placebo pressure cuff
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy with pressure cuffBehavioural
6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a cuff around the affected leg during the exercises.
Physical Therapy with placebo pressure cuffBehavioural
6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a pressure cuff around the affected leg during the exercises. The pressure cuff will have 50% of the pressure that will be considered effective.
| Study group | Role | What they receive |
|---|---|---|
| blood flow restriction therapy (pressure cuff) | Experimental | The cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on. Receives: Behavioral: Physical Therapy with pressure cuff |
| blood flow restriction therapy (placebo) | Placebo comparator | Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm Receives: Behavioral: Physical Therapy with placebo pressure cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in extensor strength of both legs
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Measured: Visit 1 Day 0
Change in extensor strength of both legs
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Measured: Visit 3 week 6
Secondary outcomes (4)
Change in recovery, muscle strength
Having bilateral thigh circumference measured
Measured: Visit 1 Day 0
Change in recovery, muscle strength
Having bilateral thigh circumference measured
Measured: Visit 1 Week 6
Change in Knee function
The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function.
Measured: Visit 1 Day 0
Change in Knee function
The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function.
Measured: Visit 3 week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Sep 2021
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillem Gonzales-Lomas, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149977
- Sponsor's protocol ID
- 19-01269
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2019
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) may be available upon reasonable request. Requests should be directed to Jordan.Fried@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study
- ClinicalTrials.gov ID
- NCT04149977
- Acronym / sponsor ID
- 19-01269
- Conditions
- Lower Limb Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 4 Nov 2019 (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 primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.
Detailed description
The purpose is to restrict venous outflow with an inflatable cuff to create a high intensity environment increases muscle hypertrophy, thus promoting a more efficient form of rehabilitation. Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff. The cuff is placed around the desired limb before a specific exercise, the physical therapist determines the appropriate pressure and time, and the patient completes the exercise as they normally would. The monitor determines the limb occlusion pressure and has an automatic timer that will deflate after the specified time has elapsed. There are also audio and visual alarms that alert the user of under or over pressurization. The specific pressure will vary based on patient's tolerance and will stay consistent through each exercise. Thus far blood flow restriction therapy has been tested in patients with several pathologies but there is limited literature on its effect on lower limb extensor injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood flow restriction therapy (pressure cuff) | Experimental | Behavioral: Physical Therapy with pressure cuffThe cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on. |
| blood flow restriction therapy (placebo) | Placebo comparator | Behavioral: Physical Therapy with placebo pressure cuffPatients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Physical Therapy with pressure cuff6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a cuff around the affected leg during the exercises. | Behavioural | blood flow restriction therapy (pressure cuff) |
| Physical Therapy with placebo pressure cuff6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a pressure cuff around the affected leg during the exercises. The pressure cuff will have 50% of the pressure that will be considered effective. | Behavioural | blood flow restriction therapy (placebo) |
Primary outcome
Change in extensor strength of both legs
Time frame: Visit 1 Day 0
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Change in extensor strength of both legs
Time frame: Visit 3 week 6
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
4 secondary outcomes
Change in recovery, muscle strength
Time frame: Visit 1 Day 0
Change in recovery, muscle strength
Time frame: Visit 1 Week 6
Change in Knee function
Time frame: Visit 1 Day 0
Change in Knee function
Time frame: Visit 3 week 6
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 26 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) may be available upon reasonable request. Requests should be directed to Jordan.Fried@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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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.
Guillem Gonzales-Lomas, MD principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy with pressure cuff in people with Lower Limb Injury, run by NYU Langone Health 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 26 Sep 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Samy Shelbaya (517-575-5522, Samy.shelbaya@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in extensor strength of both legs (time frame: Visit 1 Day 0). The study lists 2 primary outcomes in all. 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 26 Sep 2025.