Blood Flow Restriction Therapy in Achilles Injury

NCT04104126 | Recruiting

• 1 other identifier: s19-01244
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Standard of Care Physical Therapy

ACTIVE COMPARATOR

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

Blood flow restriction (BFR) therapy

EXPERIMENTAL

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

Interventions

Standard of Care Physical Therapy OTHER

Will receive standard of care physical therapy

Standard of Care Physical Therapy

Blood flow restriction OTHER

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.

Blood flow restriction (BFR) therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Guillem Gonzalez-Lomas, MD

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Chen

CONTACT

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

Michael Moore

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: October 8, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Requests should be directed to David.Bloom@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)