Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Therapy with pressure cuff, Physical Therapy with placebo pressure cuff.
- Who it may be relevant to
- Registry conditions: Lower Limb Injury. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study
Overview
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.
Interventions
- Behavioral Physical Therapy with pressure cuff
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. - Behavioral Physical Therapy with placebo pressure cuff
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.
Primary outcome measures
- Change in extensor strength of both legs [Time frame: Visit 1 Day 0]
- Change in extensor strength of both legs [Time frame: Visit 3 week 6]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT04149977 · 19-01269