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Clinical Trial NCT07498166 for Achilles Tendon Rupture, Blood Flow Restriction Therapy, Achilles Tendon Repairs/Reconstructions, Dynamic Blood Flow Restriction is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair 75 Randomized Exercise-Based Personalized Treatment

Active, not recruiting
Clinical Trial NCT07498166 is an interventional study for Achilles Tendon Rupture, Blood Flow Restriction Therapy, Achilles Tendon Repairs/Reconstructions, Dynamic Blood Flow Restriction that is active, not recruiting. It started on February 1, 2026 with plans to enroll 75 participants. Led by Massachusetts General Hospital, it is expected to complete by February 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief Summary
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 wi...

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Detailed Description
Achilles tendon rupture (ATR) is a common musculoskeletal injury that frequently results in prolonged functional impairment despite successful surgical repair. Even with modern operative techniques and standardized rehabilitation protocols, many patients demonstrate persistent weakness of the gastrocnemius-soleus complex, deficits in ankle plantarflexion strength, and delayed return to activity. These deficits are th...Show More
Official Title

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

Conditions
Achilles Tendon RuptureBlood Flow Restriction TherapyAchilles Tendon Repairs/ReconstructionsDynamic Blood Flow Restriction
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • IRB#2026P000071
NCT ID Number
NCT07498166
Start Date (Actual)
2026-02-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-02-01
Enrollment (Estimated)
75
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Achilles Tendon
Tendon Injuries
Blood Flow Restriction Training
Achilles Rehabilitation
Postoperative Physical Therapy
Hypoxic Muscle Recovery
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBlood 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 Hos...Show More
Blood Flow Restriction Resistance Training (BFR-RT)
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 stre...Show More
Standard Physical Therapy
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.
Sham ComparatorSham 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.
Sham Blood Flow Restriction
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
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.
Active ComparatorStandard 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.
Standard Physical Therapy
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Achilles Tendon Total Rupture Score (ATRS)
The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome instrument used to assess symptoms and physical function following Achilles tendon rupture. The score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms.
12 months postoperatively
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Ankle Plantarflexion Isometric Strength (Limb Symmetry Index)
Isometric ankle plantarflexion strength will be measured using the Fysiometer platform. Results will be expressed as limb symmetry index (LSI), calculated as the ratio of injured limb strength to contralateral limb strength expressed as a percentage.
3 months, 4.5 months, 6 months, and 12 months postoperatively
Gastrocsoleus Muscle Cross-Sectional Area
Cross-sectional area of the gastrocnemius-soleus muscle complex measured using portable ultrasound imaging to quantify muscle morphology and recovery following Achilles tendon repair.
6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
Visual Analog Scale (VAS) Pain Score
Pain intensity will be measured using a 10-point Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst possible pain.
6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
PROMIS Pain Interference Score
Pain interference will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference questionnaire. Higher scores indicate greater pain interference with daily activities.
6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
PROMIS Physical Function Score
Physical function will be assessed using the PROMIS Physical Function questionnaire, which evaluates the participant's ability to perform physical activities.
6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
Foot and Ankle Ability Measure (FAAM)
The Foot and Ankle Ability Measure (FAAM) is a validated patient-reported outcome instrument assessing functional limitations related to foot and ankle conditions.
6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
Single-Leg Heel Rise Test
Functional calf endurance will be evaluated using the single-leg heel rise test measuring the number of heel raises completed on the affected limb.
3 months, 4.5 months, 6 months, and 12 months postoperatively
Single-Leg Heel Rise Height
Heel rise height will be measured during the single-leg heel rise test to assess plantarflexion strength and functional calf performance.
3 months, 4.5 months, 6 months, and 12 months postoperatively
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), which evaluates participant activity levels across multiple domains.
6 months and 12 months postoperatively
EQ-5D-5L Quality of Life Score
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.
6 months and 12 months postoperatively
Ankle Range of Motion
Active and passive ankle plantarflexion and dorsiflexion range of motion will be measured bilaterally using a goniometer.
6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
Calf Circumference
Bilateral calf circumference measurements will be obtained to assess muscle atrophy and recovery following Achilles tendon repair.
6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Adults aged 18 to 75 years
  • Acute unilateral midportion Achilles tendon rupture
  • Primary surgical repair performed within 2 weeks of injury
  • Willingness and ability to comply with the postoperative rehabilitation protocol and follow-up schedule

  • Cognitive impairment or inability to follow study instructions
  • Planned postoperative follow-up at another institution
  • Use of fluoroquinolone antibiotics or systemic corticosteroids within the past 6 months
  • Previous Achilles tendon rupture in either limb
  • Simultaneous bilateral Achilles tendon rupture
  • History of venous thromboembolism (deep venous thrombosis or pulmonary embolism)
  • Diabetes mellitus
  • Reduced lower extremity function due to conditions other than Achilles tendon rupture
  • Uncontrolled hypertension
  • Peripheral vascular disease or ankle-brachial index less than 1.0
  • Chronic kidney disease or heart failure with lower extremity edema
  • Lower extremity dialysis access
  • Lower extremity thrombophlebitis
  • Active cancer or ongoing chemotherapy treatment
  • Prior lymphadenectomy
  • Tumor or malignancy affecting the lower extremities
  • Hemophilia or other major bleeding disorders
  • Factor V Leiden mutation or known thrombophilia
  • Sickle cell anemia
  • Pregnancy
  • Surgery within the previous month
Massachusetts General Hospital logoMassachusetts General Hospital
Study Responsible Party
Diana L. Bejarano Pineda, Principal Investigator, Foot & Ankle Orthopaedic Surgeon; Director, Minimally Invasive Foot & Ankle Surgery Assistant Professor of Orthopaedic Surgery, Harvard Medical School, Massachusetts General Hospital
No contact data.
1 Study Locations in 1 Countries

Massachusetts

Massachusetts General Hospital, Department of Orthopaedics, Boston, Massachusetts, 02114, United States