Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589115
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigates the effectiveness of physical therapy augmented with blood flow restriction BFR therapy relative to standard physical therapy in patients after an open reduction and internal fixation of a closed tibial plateau fracture
The main aims are
Collect functional and patient self-reported outcomes data
Assess leg muscle atrophy
Acquire motion analysis dynamics and knee strength data
Participants will be randomized into either a rehabilitation protocol or that protocol with blood flow restriction and be followed for 1 year
The main aims are
Collect functional and patient self-reported outcomes data
Assess leg muscle atrophy
Acquire motion analysis dynamics and knee strength data
Participants will be randomized into either a rehabilitation protocol or that protocol with blood flow restriction and be followed for 1 year
Detailed Description:
Standardized Surveys Participants will complete two patient reported functional outcome assessments via questionnaires the KOOS Knee Injury and Osteoarthritis Outcome Score and the PROMIS PF Patient-Reported Outcomes Measurement Information System Physical Function The PROMIS PF is a computer adaptive reliable and validated instrument used to evaluate patient-reported outcome measures regarding physical function ranging from low to very high along with mental and social well-being The KOOS is a knee-specific self-administered questionnaire that assesses five long-term and short-term outcomes of knee injury pain symptoms activities of daily living sport and recreation function and knee-related quality of life
Blood Flow Restriction Cuff Along with standard physical therapy three of the standardized exercises will be performed while wearing an Owens Delfi blood flow restriction cuff Delfi Medical San Antonio TX To attain partial vascular occlusion an easy-fit nylon cuff 115 cm x 86 cm 5mm thick will be placed as proximal as possible on the patients thigh of the involved leg Total limb occlusion pressure will be individualized and set between 60 to 80 of the complete arterial occlusion pressure Limb occlusive pressure will be calculated with the participants in the position for exercise to ensure accurate calculation of limb occlusive pressure This individual approach prevents excessive pressure in individuals with lower limb occlusion pressures
Tape Measure A non-elastic flexible plastic tape measure will be used The thigh circumference will be measured at a point 15 cm proximal to the superior pole of the patella Calf circumference will be measured at the point of greatest circumference while subjects are supine with the knee extended subcutaneous tissues will not be compressed
Motion Analysis Quantitative motion analysis will be conducted at the Medical College of Wisconsin MCW Center for Motion Analysis CMA using a motion analysis camera system and wireless surface electromyography EMG electrodes to determine temporal-spatial parameters kinematics kinetics and muscle activity during walking sit-to-stand forward lunge and step-up-and-over tasks A validated standardized gait model will be used
Leg Strength Assessment Isometric concentric and eccentric strength will be assessed using the Biodex System 3 Pro dynamometer Each subject will undergo bilateral leg strength testing
Blood Flow Restriction Cuff Along with standard physical therapy three of the standardized exercises will be performed while wearing an Owens Delfi blood flow restriction cuff Delfi Medical San Antonio TX To attain partial vascular occlusion an easy-fit nylon cuff 115 cm x 86 cm 5mm thick will be placed as proximal as possible on the patients thigh of the involved leg Total limb occlusion pressure will be individualized and set between 60 to 80 of the complete arterial occlusion pressure Limb occlusive pressure will be calculated with the participants in the position for exercise to ensure accurate calculation of limb occlusive pressure This individual approach prevents excessive pressure in individuals with lower limb occlusion pressures
Tape Measure A non-elastic flexible plastic tape measure will be used The thigh circumference will be measured at a point 15 cm proximal to the superior pole of the patella Calf circumference will be measured at the point of greatest circumference while subjects are supine with the knee extended subcutaneous tissues will not be compressed
Motion Analysis Quantitative motion analysis will be conducted at the Medical College of Wisconsin MCW Center for Motion Analysis CMA using a motion analysis camera system and wireless surface electromyography EMG electrodes to determine temporal-spatial parameters kinematics kinetics and muscle activity during walking sit-to-stand forward lunge and step-up-and-over tasks A validated standardized gait model will be used
Leg Strength Assessment Isometric concentric and eccentric strength will be assessed using the Biodex System 3 Pro dynamometer Each subject will undergo bilateral leg strength testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None