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 range19 Years – 60 Years
SexALL
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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).
✕. Patients who have a neurovascular injury associated with the fracture
✕. Patients who have sustained bilateral lower limb injuries
✕. Patients aged \<19 and \>60
✕. Patients with known peripheral vascular disease or vascular repair
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