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The investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by the standard protocol progression for the remainder of the treatment program. The other group will receive standard post-operative rehabilitation without BFR for the duration of treatment program.
The aim is to compare strength, patient reported outcomes, and functional outcomes of post-operative therapy with and without adjunctive BFR training. To accomplish this task the investigators will compare differences in thigh girth between two groups of patients after the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0Ëš degrees of extension. In addition, isokinetic testing of the quadriceps and hamstrings will be performed at 12 weeks and 6 months post-operatively. Lower extremity girth measurements after knee surgery can be performed with good to excellent intra- and inter-rater reliability. Quadriceps strength measured with isokinetic testing is related to performance measures such as jumping. Limb circumference measurement, limb CSA measurement, and isokinetic strength testing are commonly utilized in BFR studies as outcome measures.One group will receive BFR for 12 weeks in addition to standard post-operative rehabilitation and the other group will receive standard post-operative rehabilitation without BFR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Experimental | All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. One week following surgery, subjects randomized to the BFR group will begin combining BFR with all lower extremity strengthening exercises supervised in clinic up to 3 times per week for 12 weeks. |
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| Standard rehabilitation (control group) | Active Comparator | All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction | Other | Delfi's Personalized Tourniquet System for Blood Flow Restriction has been specifically designed to safely regulate and control tourniquet pressure. Occlusion pressures will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each subject will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions). The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between 5 minute cycles. Sets and repetitions will remain constant for each subject; however, resistance will be incrementally increased after the subject is able to complete all 75 repetitions without loss of proper form. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Torque (foot-pounds), best repetition out of 15 repetitions | Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second | 12 weeks and 6 months post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Thigh circumference (centimeters) | Change in girth measurements of thigh: 10 cm from proximal patella 15 cm from proximal patella 33% length from proximal patella to inguinal crease | baseline, 6 weeks, 12 weeks, and 6 months |
| Visual Analog Scale (VAS), 0 to 40 mm self report pain scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John S Mason, DSc, DPT | Keller Army Community Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keller Army Community Hospital | West Point | New York | 10996 | United States | ||
| Womack Army Medical Center |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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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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This is a prospective, randomized control trial. After consenting, subjects will be randomized to one of two groups by using a computer generated random number.
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Investigators recording thigh girth and isokinetic data will be blinded to group assignment.
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| Standard rehabilitation | Other | Standard of care for post-operative condition |
|
Change in VAS for Pain |
| baseline, 6 weeks, 12 weeks, and 6 months |
| Lower Extremity Functional Scale (LEFS) Questionnaire | Change in LEFS Outcome Measure | baseline, 6 weeks, 12 weeks, and 6 months |
| Fort Bragg |
| North Carolina |
| 28310 |
| United States |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |