Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

Lower Limb Injury Clinical Trial

Official title:

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04149977
• Other study ID #: 19-01269
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: Michael Moore
• Phone: 347-554-0183
• Email: Michael.Moore[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leg Injuries
• Lower Limb Injury
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in extensor strength of both legs	Isokinetic strength testing with a Biodex dynamometer to measure peak torque	Visit 1 Day 0
Primary	Change in extensor strength of both legs	Isokinetic strength testing with a Biodex dynamometer to measure peak torque	Visit 3 week 6
Secondary	Change in recovery, muscle strength	Having bilateral thigh circumference measured	Visit 1 Day 0
Secondary	Change in recovery, muscle strength	Having bilateral thigh circumference measured	Visit 1 Week 6
Secondary	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.	Visit 1 Day 0
Secondary	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.	Visit 3 week 6