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.
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
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
Parallel
Blood Flow Restriction Therapy
Other interventionPersonalized Blood Flow Restriction Therapy uses an an inflatable cuff (Delfi PTS system) around the upper thigh which partially restricts arterial inflow during exercise. BFR allows for similar improvements of muscular strength and muscle mass as traditional heavy load strength training while using significantly lower loads. The reduced stress on supporting tissues ( tendons, joints, bones and ligaments) allows people who normally couldn't tolerate high loads to enhance their strength and muscle mass.
Number of participants who consent to participate
Percentage of participants approached for recruitment who consent to study participation
Number of participants self-reporting adherence to treatment protocol
Percentage of participants enrolled in the study who report to completing their prescribed post injury physiotherapy sessions
Number of participants missing data on regular assessment
Percentage of participants with missing data on regular assessment
Number of participants who withdraw from the study
Percentage of participants enrolled in the study who withdraw before completion of the study
Limb Occlusion Pressure (LOP) in millimeters of mercury (mmHg)
Participants' maximum percentage of Limb Occlusion Pressure (LOP) in millimeters of mercury (mmHg) at which all exercises could be completed
Number of participants with incomplete Limb Occlusion Pressure (LOP)
Number of participants who could not complete the exercises at any percentage of Limb Occlusion Pressure (LOP)
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University of British Columbia
Lead sponsor
AO North America
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
