Meniscus Lesion Clinical Trial
Official title:
Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery
The purpose of this study is to evaluate post-operative outcomes after meniscus surgery in participants undergoing blood flow restriction training as a rehabilitative adjunct compared to those with standard rehabilitation.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Participants who undergo surgery for arthroscopic meniscus repair Exclusion Criteria: - Participants undergoing surgery for concomitant ligamentous surgeries - Patients with Diabetes Mellitus, vascular disease, or infections of the involved extremity |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee extension torque at Week 1 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 2 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 3 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 4 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 5 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 6 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 7 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 8 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 9 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 10 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 11 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Knee extension torque at Week 12 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 1 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 2 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 3 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 4 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 5 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 6 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 7 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 8 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 9 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 10 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 11 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Primary | Thigh circumference at Week 12 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) | |
Secondary | International Knee Documentation Committee (IKDC) Score at Week 6 | Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms | 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively) | |
Secondary | International Knee Documentation Committee (IKDC) Score at Week 12 | Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms | 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively) | |
Secondary | International Knee Documentation Committee (IKDC) Score at Week 24 | Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms | 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively) | |
Secondary | Y-balance testing at Week 12 | Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100. | 3 months (performed at 3 months and 6 months post-operatively) | |
Secondary | Y-balance testing at Week 24 | Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100. | 6 months (performed at 3 months and 6 months post-operatively) | |
Secondary | 3-hop test at Week 12 | Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb. | 3 months (performed at 3 months and 6 months post-operatively) | |
Secondary | 3-hop test at Week 24 | Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb. | 6 months (performed at 3 months and 6 months post-operatively) | |
Secondary | Single leg squat testing at Week 12 | Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation & tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control | 3 months (performed at 3 months and 6 months post-operatively) | |
Secondary | Single leg squat testing at Week 24 | Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation & tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control | 6 months (performed at 3 months and 6 months post-operatively) |
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