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BFR Physical Therapy Protocol was not finalized and department had multiple similar studies.
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This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.
The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol.
To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy with BFR | Experimental | Participants will begin BFR therapy as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR will consist of the physical therapy following the surgeon's postoperative protocol. |
|
| Physical Therapy without BFR | Active Comparator | Participants will undergo standard physical therapy following the surgeon's postoperative protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Therapy | Other | BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in MRI imaging of Graft | Graft ligamentization or maturation on MRI using T2 mapping | 2 weeks, 3 months, 6 months |
| Difference in Quadriceps Volume & Cross-sectional Area | Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area | 3 months, 6 months |
| Difference in Thigh Circumference Measurement | Muscle measurement determined with measuring tape for thigh circumference | 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Isokinetic Dynamometer | Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer | 2 weeks, 3 months, 6 months |
| Visual Analog Scale (VAS) | Patient reported assessment of current level of pain from no pain to worst imaginable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Sherman, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Redwood City | California | 94063 | United States |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Standard Postoperative Physical Therapy | Other | This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction. |
|
| 2 weeks, 3 months, 6 months |
| Single Assessment Numerical Evaluation (SANE) | Patient reported outcome measure of function. 0-100% scale with 100% being normal | 2 weeks, 3 months, 6 months |
| International Knee Documentation Committee (IKDC) | Patient reported outcome measure of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | 2 weeks, 3 months, 6 months |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |