Achilles Injuries Tendon
Conditions
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.
Interventions
Will receive standard of care physical therapy
OTHERBlood 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[100-mm scale\]) |
Countries
United States
Contacts
CONTACTLarry Chen
CONTACTMichael Moore
PRINCIPAL_INVESTIGATORGuillem Gonzalez-Lomas, MD
New York Langone Health
Outcome results
None listed