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Behavioural Intervention

Blood Flow Restriction Training for Lower Extremity Fractures

N/A
Waitlist Available
Led By Megan E Smith, PT, DPT
Research Sponsored by Denver Health and Hospital Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult with closed tibial shaft fracture
Be older than 18 years old
Must not have
Renal compromise
Severe uncontrolled hypertension (SBP>180)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 4, 6, 12 weeks and 6 months
Awards & highlights

Summary

This trial will investigate the impact of using a blood flow restriction device during light strengthening exercises on patients with tibial shaft fractures. It will compare the muscle strength, muscle size, healing of the fracture

Who is the study for?
This trial is for individuals with tibial shaft fractures. Participants should be able to perform low load strengthening exercises and must not have conditions that would interfere with exercise or use of a blood flow restriction device.
What is being tested?
The study compares the effectiveness of using a blood flow restriction device during therapeutic exercises versus doing the exercises without it, focusing on muscle strength, size, fracture healing, and recovery time.
What are the potential side effects?
Potential side effects may include discomfort from the blood flow restriction device, muscle soreness due to exercise, and possible skin irritation at the site where the device is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a closed fracture in my tibia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is not normal.
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My blood pressure is not higher than 180.
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I have lymphedema.
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I am under 18 years old.
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I have been diagnosed with osteoporosis or osteopenia.
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I have poor blood flow in my limb.
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I currently have a deep vein thrombosis.
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I have a clotting disorder or a high risk of blood clots.
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I have sickle cell anemia.
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I have an infection in my arm or leg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 4, 6, 12 weeks and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 4, 6, 12 weeks and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fracture healing
Secondary study objectives
Muscle girth
Muscle strength
Physical function

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Blood flow restriction trainingExperimental Treatment1 Intervention
Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device
Group II: Traditional physical therapyActive Control1 Intervention
Patients perform physical therapy exercises guided by a Doctor of Physical Therapy without the use of a blood flow restriction device, as is current standard practice.

Find a Location

Who is running the clinical trial?

Denver Health and Hospital AuthorityLead Sponsor
104 Previous Clinical Trials
402,081 Total Patients Enrolled
Megan E Smith, PT, DPTPrincipal InvestigatorDenver Health
~27 spots leftby Jan 2026
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