Blood Flow Restriction Therapy in Achilles Injury

Study Overview
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Brief Summary
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Blood flow restriction (BFR) therapy is a brief and partial restriction of venous outflow of an extremity during low load resistance exercises. It is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. This prospective, randomized study will look at the implications this form of treatment has on the rehabilitation of Achilles injuries.

Official Title
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Blood Flow Restriction Therapy in Achilles Injury

Conditions
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Achilles Injuries Tendon

Intervention / Treatment
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* Other: Standard of Care Physical Therapy
* Other: Blood flow restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Achilles Injury Must be at least 18 years of age and younger than 65 years of age Intention to receive physical therapy as standard of care Exclusion Criteria: Patients with intention to receive standard therapy and not the study therapy Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension Younger than 18 years of age or older than 65 Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.) Any patient considered a vulnerable subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Physical Therapy<br>Patients with Achilles injury are prescribed PT for their treatment, therefore physical therapy is a standard of care treatment for patients with tendon pathology. | Other: Standard of Care Physical Therapy<br>* Will receive standard of care physical therapy<br>|
| Experimental: Blood flow restriction (BFR) therapy<br>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. | Other: Blood flow restriction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength | Measure in increase of strength in the affected leg measured by Biodex. | 12 Months | 
| Measure of pain using Visual Analog Scale (VAS) | Respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) | 12 Months |