Blood Flow Restriction Therapy in Achilles Injury
ConditionAchilles Injuries Tendon
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of Care Physical Therapy
Other interventionWill receive standard of care physical therapy
Blood flow restriction
Other interventionBlood 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.
Treatment groups
57 Participants
are divided into 2 treatment groupsGroup A: Standard of Care Physical TherapyActive comparator 1 intervention
Group B: Blood flow restriction (BFR) therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 Months2
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 \[100-mm scale\])
Time frame
12 MonthsSponsors and contacts
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Source ClinicalTrials.gov