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The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.
The purpose is to restrict venous outflow with an inflatable cuff to create a high intensity environment increases muscle hypertrophy, thus promoting a more efficient form of rehabilitation. Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff. The cuff is placed around the desired limb before a specific exercise, the physical therapist determines the appropriate pressure and time, and the patient completes the exercise as they normally would. The monitor determines the limb occlusion pressure and has an automatic timer that will deflate after the specified time has elapsed. There are also audio and visual alarms that alert the user of under or over pressurization. The specific pressure will vary based on patient's tolerance and will stay consistent through each exercise. Thus far blood flow restriction therapy has been tested in patients with several pathologies but there is limited literature on its effect on lower limb extensor injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blood flow restriction therapy (pressure cuff) | Experimental | The cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on. |
|
| blood flow restriction therapy (placebo) | Placebo Comparator | Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy with pressure cuff | Behavioral | 6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a cuff around the affected leg during the exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in extensor strength of both legs | Isokinetic strength testing with a Biodex dynamometer to measure peak torque | Visit 1 Day 0 |
| Change in extensor strength of both legs | Isokinetic strength testing with a Biodex dynamometer to measure peak torque | Visit 3 week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in recovery, muscle strength | Having bilateral thigh circumference measured | Visit 1 Day 0 |
| Change in recovery, muscle strength | Having bilateral thigh circumference measured |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samy Shelbaya | Contact | 517-575-5522 | Samy.shelbaya@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Guillem Gonzales-Lomas, MD | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) may be available upon reasonable request.
Requests should be directed to Jordan.Fried@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data.
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| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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double blind
| Physical Therapy with placebo pressure cuff | Behavioral | 6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a pressure cuff around the affected leg during the exercises. The pressure cuff will have 50% of the pressure that will be considered effective. |
|
| Visit 1 Week 6 |
| Change in Knee function | The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function. | Visit 1 Day 0 |
| Change in Knee function | The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function. | Visit 3 week 6 |