Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair (NCT07498166)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to determine whether blood flow restriction resistance training (BFR-RT) improves postoperative muscle recovery and functional outcomes following primary surgical repair of acute Achilles tendon rupture (ATR) in adults undergoing standard rehabilitation. The main questions it aims to answer are: Does patient-specific BFR-RT improve ankle plantarflexion strength recovery compared with sham BFR-RT or standard rehabilitation alone? Does BFR-RT improve gastrocnemius-soleus muscle morphology and patient-reported functional outcomes following ATR repair? Researchers will compare (1) BFR-RT combined with standard physical therapy, (2) sham BFR-RT combined with standard physical therapy, and (3) standard physical therapy alone to determine whether BFR-RT enhances muscle recovery, functional outcomes, and return-to-activity timelines following surgical ATR repair. Participants will: Be randomized to BFR-RT + standard physical therapy, sham BFR-RT + standard physical therapy, or standard physical therapy alone Perform supervised rehabilitation exercises using a personalized tourniquet system calibrated to limb occlusion pressure (LOP) depending on group allocation Undergo isometric ankle plantarflexion strength testing using the Fysiometer platform Receive ultrasound imaging of the gastrocnemius-soleus complex to assess muscle cross-sectional area Complete patient-reported outcome measures assessing pain and physical function Attend follow-up evaluations at 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
Who can join: Review the eligibility criteria below.
Location: Massachusetts General Hospital, Department of Orthopaedics — Boston, Massachusetts
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Massachusetts General Hospital, Department of Orthopaedics — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Achilles Tendon Rupture
- Barriers to Efficient PACU Discharge at a Major Academic Orthopaedic Ambulatory Surgery Center — New York, New York
- Effect of BFR Rehab After Achilles Tendon Rupture — Houston, Texas
Explore by condition: All Achilles Tendon Rupture clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.