Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb F… (NCT07103252) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb Fractures
Canada20 participantsStarted 2025-09-01
Plain-language summary
This study will assess the feasibility and effectiveness of blood flow restriction therapy in patients with tibia fractures (or lower leg bone). Personalized blood flow restriction therapy has shown to help people regain muscle size and strength after surgical treatment by allowing them to be able to start physiotherapy on their injured leg sooner. This study aims to evaluate the feasibility and effectiveness of personalized blood flow restriction therapy to improve thigh muscle size and strength in patients with lower limb tibia fractures which require a period of non-weightbearing.
Who can participate
Age range
19 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients aged 19-60 who have sustained an isolated (single bone/area as per AO/OTA classification) unilateral lower limb fracture of the tibia that requires a period of 6 weeks of protected weight bearing (non-weight bearing or toe touch weight bearing)
. Must speak English
. Must be able to comply with protected weight bearing instructions for at least 6 weeks
. Must be able to consent for inclusion into the trial
Exclusion criteria
. Patients who have sustained multiple fractures in the same limb (i.e. AO/OTA 3 and 4, or 4 and 8 etc).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who consent to participate
Timeframe: 12 weeks
2
Number of participants self-reporting adherence to treatment protocol
Timeframe: 12 weeks
3
Number of participants missing data on regular assessment
Timeframe: 12 weeks
4
Number of participants who withdraw from the study
Timeframe: 12 weeks
5
Number of participants who complete follow up at 12 weeks
Timeframe: 12 weeks
6
Muscle strength tension and compression in pounds
Timeframe: 0, 2, 6, 12 weeks post injury/surgery
7
Muscle size of the affected limb measured in centimeters