Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
57 participants
INTERVENTIONAL
2021-10-08
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard of Care Physical Therapy
Patients with Achilles injury are prescribed PT for their treatment, therefore physical therapy is a standard of care treatment for patients with tendon pathology.
Standard of Care Physical Therapy
Will receive standard of care physical therapy
Blood flow restriction (BFR) therapy
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.
Blood flow restriction
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.
Interventions
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Standard of Care Physical Therapy
Will receive standard of care physical therapy
Blood flow restriction
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Guillem Gonzalez-Lomas, MD
Role: PRINCIPAL_INVESTIGATOR
New York Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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s19-01244
Identifier Type: -
Identifier Source: org_study_id
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