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
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 thought to arise from a combination of postoperative immobilization, restricted early loading, and muscle atrophy during the early phases of recovery. Conventional postoperative rehabilitation protocols typically emphasize gradual progression of low-load resistance training to protect the healing tendon. While these protocols prioritize tendon safety, they may provide insufficient mechanical and metabolic stimulus to promote optimal muscle hypertrophy and neuromuscular recovery during the early postoperative period. Blood flow restriction resistance training (BFR-RT) has emerged as a potential strategy to enhance muscular adaptation while using low mechanical loads. By applying controlled external pressure to the proximal limb during exercise, BFR-RT produces localized hypoxia and metabolic stress that can stimulate anabolic signaling pathways associated with muscle hypertrophy and strength gains. Prior studies in orthopedic and sports rehabilitation settings-including anterior cruciate ligament reconstruction and chronic Achilles tendinopathy-have demonstrated that low-load BFR-RT can produce physiologic adaptations comparable to traditional high-load resistance training while minimizing mechanical stress on healing tissues. However, the efficacy and safety of BFR-RT during the early rehabilitation period following primary ATR repair have not been evaluated in a prospective randomized clinical trial. This study is designed as a prospective, three-arm randomized controlled trial to evaluate whether integrating BFR-RT into postoperative ATR rehabilitation improves early muscle recovery and functional outcomes while maintaining an acceptable safety profile. Participants undergoing primary surgical repair for an acute unilateral mid-portion ATR will be randomized to one of three rehabilitation protocols: BFR-RT combined with standard physical therapy, sham BFR-RT combined with standard physical therapy, or standard physical therapy alone. The BFR intervention will be delivered using a personalized tourniquet system that determines limb occlusion pressure for each participant to standardize vascular restriction and minimize inter-individual variability in occlusion levels. Participants will undergo standardized postoperative rehabilitation and will be followed longitudinally over a 12-month recovery period. Clinical assessments will be performed at predefined postoperative intervals to evaluate physiologic recovery of the gastrocnemius-soleus complex and patient-centered functional outcomes. Safety monitoring will include systematic documentation of potential adverse events associated with postoperative rehabilitation or vascular restriction techniques. By evaluating the physiologic and clinical effects of patient-specific BFR-RT following surgical ATR repair, this study aims to generate evidence regarding whether low-load metabolic training can safely accelerate muscle recovery and improve functional rehabilitation outcomes in this population. Findings from this trial may inform future postoperative rehabilitation protocols and help define the role of BFR-RT as an adjunctive strategy in tendon repair recovery pathways.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
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.
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.
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.
Massachusetts General Hospital, Department of Orthopaedics
Boston, Massachusetts, United States
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.
Time frame: 12 months postoperatively
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.
Time frame: 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.
Time frame: 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. Higher scores indicate greater pain severity.
Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Pain interference will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference questionnaire. Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population; scores range from approximately 41 to 77, with higher scores indicating greater pain interference with daily activities.
Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Physical function will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire, which evaluates the participant's ability to perform physical activities. Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population; higher scores indicate better physical function.
Time frame: 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. Scores range from 0 to 100, with higher scores indicating greater functional ability.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 (EuroQol 5-Dimension 5-Level) questionnaire. The EQ-5D-5L index score ranges from 0 to 1, with higher scores indicating better health-related quality of life. A visual analogue scale (VAS) component ranges from 0 to 100, with higher scores indicating better self-rated health.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.