Blood Flow Restriction Therapy in Achilles Injury

Not Applicable

Recruiting

• Conditions: Achilles Injuries Tendon
• Interventions: Other: Blood flow restriction; Other: Standard of Care Physical Therapy

• Registration Number: NCT04104126
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Start: 2021-10-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood flow restriction (BFR) 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.
Standard of Care Physical Therapy	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.

Primary Outcome Measures

Name	Time	Method
efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength	12 Months	Measure in increase of strength in the affected leg measured by Biodex.
Measure of pain using Visual Analog Scale (VAS)	12 Months	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 \[100-mm scale\])

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States