Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
ConditionLower Limb Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Therapy with pressure cuff
Behavioral6 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 cuff
Behavioral6 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: blood flow restriction therapy (pressure cuff)Experimental treatment 1 intervention
Group B: blood flow restriction therapy (placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in extensor strength of both legs
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Time frame
Visit 1 Day 02
Change in extensor strength of both legs
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Time frame
Visit 3 week 6Secondary outcomes
1
Change in recovery, muscle strength
Having bilateral thigh circumference measured
Time frame
Visit 1 Day 02
Change in recovery, muscle strength
Having bilateral thigh circumference measured
Time frame
Visit 1 Week 63
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.
Time frame
Visit 1 Day 04
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.
Time frame
Visit 3 week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov