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New treatment option for Lower Limb Injury
Official title Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
ClinicalTrials.gov ID: NCT04149977
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Legally incompetent or mentally impaired (e.g. minors, Alzheimer's people, 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
See the full eligibility 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
- Legally incompetent or mentally impaired (e.g. minors, Alzheimer's people, 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.