Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07498166
Status
Active Not Recruiting

Conditions

  • Achilles Tendon Repairs/Reconstructions
  • Achilles Tendon Rupture
  • Blood Flow Restriction Therapy
  • Dynamic Blood Flow Restriction

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Blood Flow Restriction Resistance Training (BFR-RT) — DEVICE
    Blood flow restriction resistance training will be performed using the Delfi Personalized Tourniquet System applied to the affected limb during supervised rehabilitation exercises. The device automatically determines limb occlusion pressure (LOP) and applies 80% of LOP during low-load resistance exercises. This controlled vascular restriction produces metabolic stress intended to stimulate muscle hypertrophy and strength recovery while minimizing mechanical load on the healing Achilles tendon. Sessions are conducted under physiotherapist supervision within the standardized postoperative rehabilitation protocol.
  • Sham Blood Flow Restriction — DEVICE
    Participants assigned to the sham group will wear the Delfi tourniquet cuff during rehabilitation sessions; however, cuff pressure will be inflated only to 20 mmHg, a level insufficient to induce vascular occlusion. This condition mimics the experience of the intervention device while avoiding physiologic blood flow restriction, thereby controlling for potential placebo effects associated with device use.
  • Standard Physical Therapy — BEHAVIORAL
    Participants will undergo the standardized postoperative Achilles tendon rehabilitation program used at Massachusetts General Hospital. The protocol includes progressive weight-bearing, range-of-motion exercises, strengthening maneuvers, and return-to-sport progression phases supervised by trained physiotherapists.

Study Details

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

Key Dates

Start date
Feb 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Blood Flow Restriction Resistance Training + Standard Physical Therapy
    Participants receive standard postoperative Achilles tendon rehabilitation combined with blood flow restriction resistance training using the Delfi Personalized Tourniquet System. Cuffs are calibrated to 80% limb occlusion pressure to induce controlled vascular restriction during low-load resistance exercises. All sessions are supervised by trained physiotherapists following the standardized Massachusetts General Hospital Achilles rehabilitation protocol.
  • Sham Comparator: Sham Blood Flow Restriction + Standard Physical Therapy
    Participants receive the same standardized postoperative rehabilitation protocol while wearing Delfi tourniquet cuffs inflated to 20 mmHg, a pressure insufficient to induce blood flow restriction. This sham condition controls for potential placebo effects associated with the device while maintaining identical exercise protocols and therapist supervision.
  • Active Comparator: Standard Physical Therapy Alone
    Participants undergo the standardized Massachusetts General Hospital postoperative Achilles tendon rehabilitation program including range-of-motion exercises, progressive strengthening, and return-to-sport phases. No blood flow restriction device is used during rehabilitation sessions.

Primary Outcome Measure

Achilles Tendon Total Rupture Score (ATRS) [ Time Frame: 12 months postoperatively ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital, Department of OrthopaedicsBostonMassachusetts02114-

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By research site
Massachusetts General Hospital, Department of Orthopaedics· Boston, MA

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