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Blood Flow Restriction Therapy for Lower Limb Injury

N/A
Recruiting
Led By Guillem Gonzales-Lomas, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with a lower limb extensor injury (quadriceps tendon rupture, patella tendon rupture, patella fracture)
Must be at least 18 years of age and younger than 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 3 week 6
Awards & highlights

Study Summary

This trial will test whether blood flow restriction therapy can improve strength and muscle mass in people with lower limb injuries.

Who is the study for?
This trial is for adults aged 18-65 with lower limb extensor injuries who plan to undergo physical therapy. It's not suitable for those under 18 or over 65, mentally impaired individuals, people using mobility aids before injury, patients with prior similar injuries, circulation issues, severe hypertension, additional leg trauma, sickle cell anemia, venous thromboembolism or cancer.Check my eligibility
What is being tested?
The study tests the effectiveness of blood flow restriction therapy in treating lower limb extensor injuries. Participants will receive physical therapy either with a pressure cuff that restricts blood flow or a placebo cuff without this effect to compare results on muscle strength and mass.See study design
What are the potential side effects?
Potential side effects may include discomfort from the pressure cuff during treatment and possible temporary changes in skin coloration or sensation due to restricted blood flow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an injury to my lower limb's extensor (like a torn quadriceps or patella tendon, or a broken kneecap).
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 3 week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 3 week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in extensor strength of both legs
Secondary outcome measures
Change in Knee function
Change in recovery, muscle strength

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: blood flow restriction therapy (pressure cuff)Experimental Treatment1 Intervention
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.
Group II: blood flow restriction therapy (placebo)Placebo Group1 Intervention
Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,611 Total Patients Enrolled
Guillem Gonzales-Lomas, MDPrincipal InvestigatorNYU Langone

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I qualify to participate in this research experiment?

"To be eligible for inclusion in this trial, individuals must have wounds and fall within the age range of 18 to 65 years. At present, a total of 100 patients are being recruited."

Answered by AI

Are researchers currently looking for new participants to join this study?

"Affirmative. Clinicaltrials.gov contains information pointing to the fact that this experiment is actively searching for enrollees, which was first posted on July 5th 2021 and edited as recently as October 5th 2022. This research requires 100 subjects from a single medical centre."

Answered by AI

How many participants are being considered for inclusion in this research?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this medical study, originally posted July 5th 2021, is presently enrolling candidates. A total of 100 participants need to be recruited from a single location."

Answered by AI

Are individuals under the age of 45 permitted to participate in this research?

"As specified in the trial's enrollment criteria, participants must be at least 18 years old and no older than 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
2021. "Blood Flow Restriction Therapy in Lower Limb Extensor Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04149977.
~11 spots leftby Aug 2024
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