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Recruiting NCT04104126

Blood Flow Restriction Therapy in Achilles Injury

No phase Interventional Achilles Injuries Tendon

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of Care Physical Therapy, Blood flow restriction.
Who it may be relevant to
Registry conditions: Achilles Injuries Tendon. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Standard of Care Physical Therapy
    Will receive standard of care physical therapy
  • Other 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.

Primary outcome measures

  • efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength [Time frame: 12 Months]
  • Measure of pain using Visual Analog Scale (VAS) [Time frame: 12 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT04104126 · s19-01244

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗