Recruiting

Blood Flow Restriction Therapy

Sponsor:

NYU Langone Health

Code:

NCT04104126

Conditions

Achilles Injuries Tendon

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Standard of Care Physical Therapy

Blood flow restriction

Study Details

Brief summary:

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.

Conditions

Achilles Injuries Tendon

Study ID

NCT04104126

Start date

Oct 8, 2021

Status verified date

Jun, 2026

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

57 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Larry Chen

(317)847-1784Larry.Chen@nyulangone.org

Michael Moore

347-554-0183michael.moore@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10017

Contacts

Zachary Li

317-517-0426zachary.li@nyulangone.org

Principal Investigator:

Guillem Gonzalez-Lomas, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-08.