Blood Flow Restriction Therapy in Achilles Injury

Achilles Injuries Tendon Clinical Trial

Official title:

Blood Flow Restriction Therapy in Achilles Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04104126
• Other study ID #: s19-01244
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Michael Moore
• Phone: 3475540183
• Email: michael.moore[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Injuries Tendon
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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