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Blood Flow Restriction Therapy for Hip Fracture
N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Segmental and pathologic femur fractures are excluded.
Isolated, closed proximal femur fracture without any prior surgery or orthopedic implants to affected proximal femur. This includes all fractures with primary fracture line that is proximal to the lesser trochanter. For example, subtrochanteric femur fractures are excluded whereas reverse obliquity intertrochanteric femur fractures may be included.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post op 2 weeks
Awards & highlights
Study Summary
This trial will study the effects of BFR combined with physical therapy on elderly patients who have had surgery for a hip fracture.
Who is the study for?
Elderly patients aged 65 or older who have had surgery for a hip fracture can join this trial. They must have been able to walk half a mile before the injury, speak English, and be capable of light exercise. Those with severe obesity, uncontrolled high blood pressure, recent surgeries on legs, COVID-19 infection, history of deep vein thrombosis (DVT), or conditions increasing coagulopathy risk cannot participate.Check my eligibility
What is being tested?
The study is testing if adding Blood Flow Restriction therapy to regular post-surgery physical therapy helps elderly patients recover better from hip fractures. Participants will use the Delfi Tourniquet System Cuff during their rehabilitation exercises.See study design
What are the potential side effects?
Potential side effects may include discomfort at the cuff site, temporary numbness or tingling in the limb due to restricted blood flow during therapy sessions. There's also a low risk of bruising or skin irritation under the cuff.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have a broken thigh bone due to disease.
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I have a hip fracture that hasn't been operated on or has no implants.
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I was able to walk without help before my injury.
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I am 65 years old or older.
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I am mentally capable of understanding and agreeing to the study.
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I can put weight on my leg as much as I can handle after surgery.
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I haven't had surgery or injury to my opposite leg in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post op 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post op 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective muscle strength measured by a handheld dynamometer
Participant self-reported outcome for pain
Participant self-reported outcome: Perceived Exertion (Borg Rating of Perceived Exertion)
+2 moreSecondary outcome measures
12-Item Short Form Health Survey (SF-12) (Mental Health Component)
12-Item Short Form Health Survey (SF-12) (Physical Health Component)
Five-times sit to stand test
+5 moreOther outcome measures
Number of patient-reported falls
Post-operative complications: Blood Clots
Post-operative complications: Deep Infection
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES)Experimental Treatment1 Intervention
The intervention group will start with a Delfi tourniquet system cuff set on a limb occlusion pressure (LOP) of 60-100%. The intervention group will also use a neuromuscular electrical stimulation device at therapeutic level in addition to BFR.
Group II: Routine Post-operative Physical TherapyActive Control1 Intervention
The control group will undergo routine post-op and undergo a modified version of the graduated therapy protocol.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,024 Total Patients Enrolled
David A Patch, MDStudy DirectorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe obesity with a body mass index (BMI) over 40.I do not have severe issues that would prevent me from following up on treatment.You can walk about 0.5 mile without feeling much pain or getting too out of breath.I have a hip fracture that hasn't been operated on or has no implants.I do not have a broken thigh bone due to disease.I have a history of sickle cell anemia, peripheral arterial disease, dementia, or actively treated cancer.I have had surgery or an injury on my leg that prevents the use of a tourniquet.I'm not familiar with the specific context of "OTA codes 31A, 31B, and 31C." If you provide more details or specify the field or industry to which these codes belong, I can assist you further.I was able to walk without help before my injury.I am 65 years old or older.I am mentally capable of understanding and agreeing to the study.I have a history of blood clots in my limbs or conditions that increase my risk of clotting.I was admitted to the ICU after surgery.I have varicose veins in my legs.You were living in the community before the injury occurred.I can put weight on my leg as much as I can handle after surgery.Your post-surgery x-rays show that the implant may not be secure, which could lead to problems.I have no health conditions that stop me from bearing weight after surgery.I have an injury on my leg that prevents the use of a tourniquet.I am taking medication or supplements that could increase my risk of blood clots.You waited more than three days to get medical help for your hip fracture.I had surgery on my leg within the last year.My blood pressure is very high and was measured as such more than once before surgery.You have tested positive for COVID-19.I have other serious injuries needing surgery besides my hip injury.I haven't had surgery or injury to my opposite leg in the last year.I have had a stent placed or got a pacemaker in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Routine Post-operative Physical Therapy
- Group 2: Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively participating in the trial at present?
"Affirmative, according to clinicaltrials.gov this research is recruiting participants. The listing was first published on January 1st 2022 and the data has been refreshed as recently as 26th of that same month. Altogether, 20 patients are being sought for this trial at a single medical centre."
Answered by AI
Are there any openings remaining in this research initiative?
"Affirmative, according to the information on clinicaltrials.gov this medical trial is currently accepting participants. This research was first presented on January 1st, 2022 and has been recently altered as of January 26th, 2022. The investigators are looking for 20 people from a single site."
Answered by AI
What is the main aim of this medical experiment?
"This clinical trial is to be evaluated over a two week period in order to analyse therapist-reported compliance and adverse events. Secondary outcomes include PROMIS, SF-12 Physical Health Component, and Pain Medicine Requirements During 2 Week Stay. The former assesses physical, mental and social health with higher scores reflecting more of the concept measured; 40 points equates to one standard deviation lower than the mean while 60 points equals one standard deviation above it. SF-12's summary score has an average of 50 points with 10 being its standard deviation whereas pain medicine requirements during stay looks at milligram morphine equivalents used for managing discomfort."
Answered by AI
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