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Blood Flow Restriction Therapy for Achilles Tendon Injury
N/A
Recruiting
Led By Guillem Gonzalez-Lomas, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with Achilles Injury
Must be at least 18 years of age and younger than 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will look at the effects of blood flow restriction therapy on Achilles tendon rehab.
Who is the study for?
This trial is for adults aged 18-65 with an Achilles tendon injury who plan to undergo standard physical therapy. It's not suitable for those under 18 or over 65, individuals with mental impairments, patients not opting for the study therapy, vulnerable subjects, or anyone with poor blood circulation or severe high blood pressure.Check my eligibility
What is being tested?
The study is testing Blood Flow Restriction (BFR) Therapy alongside regular physical therapy exercises to see if it helps improve strength and recovery in people rehabilitating from Achilles injuries. Participants will be randomly assigned to receive either BFR or just standard care.See study design
What are the potential side effects?
While BFR is generally safe, potential side effects may include discomfort at the restriction site, temporary numbness, bruising, and in rare cases circulatory complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with an Achilles injury.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure of pain using Visual Analog Scale (VAS)
efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Blood flow restriction (BFR) therapyExperimental Treatment1 Intervention
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.
Group II: Standard of Care Physical TherapyActive Control1 Intervention
Patients with Achilles injury are prescribed PT for their treatment, therefore physical therapy is a standard of care treatment for patients with tendon pathology.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,626 Total Patients Enrolled
Guillem Gonzalez-Lomas, MDPrincipal InvestigatorNew York Langone Health
3 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have poor blood flow in my limbs, had surgery to improve this, or have severe high blood pressure.I plan to undergo physical therapy as part of my treatment.I have been diagnosed with an Achilles injury.I plan to receive the standard treatment, not the study therapy.I am either under 18 or over 65 years old.I am between 18 and 65 years old.I am legally competent and mentally sound.You are considered a vulnerable individual.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Physical Therapy
- Group 2: Blood flow restriction (BFR) therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the approximate number of individuals who are eligible to participate in this trial?
"Affirmative. According to the clinicaltrials.gov portal, recruitment for this medical test is ongoing since its initial posting on October 8th 2021 and last update on November 23rd 2022. Specifically, 100 individuals are sought from a single site."
Answered by AI
Is there an age limitation on enrollment for this medical experiment?
"This clinical trial is available to individuals aged 18-65 who meet the requirements."
Answered by AI
What type of people is this medical trial seeking for involvement?
"A maximum of 100 individuals, 18 years and older but younger than 65 years old, with achilles tendon injuries will be admitted to this study. In order to qualify for admittance, applicants must meet the chronological requirements outlined above."
Answered by AI
Are researchers currently recruiting participants for this experiment?
"Per information on clinicaltrials.gov, this study is in the process of enrolling participants. This trial was initially posted on October 8th 2021 and has been most recently amended on November 23rd 2022."
Answered by AI
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