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Blood Flow Restriction Therapy in Achilles Injury

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NYU Langone Health

Status

Enrolling

Conditions

Achilles Injuries Tendon

Treatments

Other: Blood flow restriction
Other: Standard of Care Physical Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04104126
s19-01244

Details and patient eligibility

About

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.

Enrollment

57 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

57 participants in 2 patient groups

Standard of Care Physical Therapy
Active Comparator group
Description:
Patients with Achilles injury are prescribed PT for their treatment, therefore physical therapy is a standard of care treatment for patients with tendon pathology.
Treatment:
Other: Standard of Care Physical Therapy
Blood flow restriction (BFR) therapy
Experimental group
Description:
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.
Treatment:
Other: Blood flow restriction

Trial contacts and locations

1

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Central trial contact

Larry Chen; Michael Moore

Data sourced from clinicaltrials.gov

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