Back to resultsBlood Flow Restriction Therapy in Achilles Injury
Primary Purpose
Achilles Injuries Tendon
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Physical Therapy
Blood flow restriction
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Injuries Tendon
Eligibility Criteria
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
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care Physical Therapy
Blood flow restriction (BFR) therapy
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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])
Secondary Outcome Measures
Full Information
NCT ID
NCT04104126
First Posted
September 24, 2019
Last Updated
September 27, 2023
Sponsor
NYU Langone Health
1. Study Identification
Unique Protocol Identification Number
NCT04104126
Brief Title
Blood Flow Restriction Therapy in Achilles Injury
Official Title
Blood Flow Restriction Therapy in Achilles Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Injuries Tendon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Physical Therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Blood flow restriction (BFR) therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Standard of Care Physical Therapy
Intervention Description
Will receive standard of care physical therapy
Intervention Type
Other
Intervention Name(s)
Blood flow restriction
Intervention 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. 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 Information:
Title
efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength
Description
Measure in increase of strength in the affected leg measured by Biodex.
Time Frame
12 Months
Title
Measure of pain using Visual Analog Scale (VAS)
Description
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])
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Moore
Phone
3475540183
Email
michael.moore@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillem Gonzalez-Lomas, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Li
Phone
317-517-0426
Email
zachary.li@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Guillem Gonzalez-Lomas, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing Access Criteria
Requests should be directed to David.Bloom@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Blood Flow Restriction Therapy in Achilles Injury
We'll reach out to this number within 24 hrs