Denver Health Medical Center
Denver, Colorado, 80204, United States
Location status: Recruiting
Location contact
Mathew A Haager, PT, DPT
CONTACT
Megan E Smith, PT, DPT
CONTACT
NCT Number: NCT06496035
This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Denver, Colorado, 80204, United States
Location status: Recruiting
Mathew A Haager, PT, DPT
CONTACT
Megan E Smith, PT, DPT
CONTACT
This study will examine the effect of blood flow restriction (BFR) training in patients with lower extremity fractures. Patients with tibial shaft fractures will be assigned to either the BFR group or control group. The BFR group will perform exercises with a blood flow restriction device, which occludes venous blood flow in the limb, while performing strengthening exercises as directed by a Doctor of Physical Therapy. The control group will perform the exercises without the device, as is current standard practice in physical therapy. Blood flow restriction training has been shown to prevent strength loss and muscle atrophy after surgery or injury, and studies suggest that it increases biomarkers of bone metabolism and tissue healing. The goal of this study is to examine the use of BFR in trauma patients using a defined protocol, and compare fracture healing, muscle strength, muscle girth, and subjective physical function between groups.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cuff/tourniquet will be applied to proximal leg at hip crease and inflated to 60-80% of limb occlusion pressure to decrease venous blood flow in the limb while performing exercise.
Exercise performed at appropriate load as guided by physical therapist
Time frame: 6 weeks, 12 weeks, 6 months
Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures
Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months
Knee extension and ankle plantarflexion strength measured with a dynamometer
Time frame: 2, 4, 6, 12 weeks and 6 months
Quadriceps and gastrocnemius muscle girth measured 15 cm above and below joint line
Time frame: 2, 6,12 weeks and 6 months
Subjective measure of function measured by Lower Extremity Functional Scale (LEFS)
Contact information is provided by the study sponsor or research team.
Mathew A Haager, PT, DPT
CONTACT
Megan E Smith, PT, DPT
CONTACT
Denver Health and Hospital Authority
Other
Blood Flow Restriction Training Versus Traditional Rehab in Patients With Lower Extremity Fractures: Effect on Fracture Healing, Muscle Strength and Girth, and Return to Function
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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