An interventional study of Blood flow restriction training (smart-cuff pro device) and Standardised strength training in Achilles Tendon Rupture and Blood Flow Restriction Therapy, sponsored by University Hospital, Ghent. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to investigate whether rehabilitation with blood flow restriction (BFR) offers added value compared to conventional rehabilitation in patients undergoing surgical repair for Achilles tendon rupture. The study will include adult patients of all sexes who have undergone surgical treatment at two selected hospitals.
The main questions it aims to answer are:
Does BFR-enhanced rehabilitation improve functional recovery compared to conventional rehabilitation? What are the effects of BFR on muscle strength and tendon recovery?
Researchers will compare blood flow restriction (BFR) therapy with conventional rehabilitation to determine whether BFR leads to improved clinical, muscular, and tendon-related outcomes.
Participants will:
Take part in follow-up assessments at weeks 4, 8, 12, 18, 24, and 52, which will include:
University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
control group: patients in this group will undergo the same standard strength training program as the BFR-group, but without a tourniquet.
Other: Standardised strength training
patients in this group will undergo a standard strength training program combined with an occlusion cuff. The cuff will be used during exercises targeting quadriceps and calf muscles.
Device: Blood flow restriction training (smart-cuff pro device)
This group will undergo low load strength training consisting of calf, thigh, glute and core exercises. A Blood flow restriction cuff will be added during selected exercises in rehabilitation program (targeting quadriceps and calf muscles)
Also known as: Kaatsu, Partial vascular occlusion
This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.
Achilles tendon rupture score (ATRS)
The ATRS is a validated 10-item (score 0-10) self-report questionnaire designed specifically for Achilles tendon rupture patients. total scores range from 0-100, with a higher score representing worst symptoms and physical activity.
Time frame: From enrollment week 0 (pre-injury score), week 12, week 18 and week 24 (the end of treatment at 6 months post-operative). Follow-up screening at week 52
US: tendon cross-sectional area
measured by ultrasound
Time frame: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52
US: tendon length
Description: measured by ultrasound
Time frame: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52
SWE: tendon stiffness
Tendon stiffness measured by Shear Wave Elastography, range 0-800kPa with higher kPa representing higher stiffness
Time frame: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52
Power doppler
Doppler signal for vascularisation
Time frame: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52
Heel rise endurance test
The Heel Rise Endurance Test (HRET) is a functional assessment used to evaluate calf muscle endurance and strength following an Achilles tendon rupture. It involves repeatedly raising up onto the toes (heel raises) on one leg until exhaustion, with the number of repetitions recorded as a measure of performance. This test helps quantify the recovery of plantar flexion strength and endurance after injury. Combined with a linear encoder, also heel rise height and work is calculated.
Time frame: week 18, week 24 Follow-up at week 52
Possibility to perform one heel rise
Physical test where the patient is assessed based on the ability to perform one heel rise. Yes/no
Time frame: week 12
Plantarflexion strength
Isokinetic strength test measured by dynamometry (Biodex)
Time frame: week 18, week 24, Follow-up at week 52
Tampa scale of kinesophobia (TSK)
The Tampa Scale for Kinesiophobia (TSK) is a 17-item self-report questionnaire used to assess fear of movement or re-injury (kinesiophobia) in individuals, particularly those with musculoskeletal pain. It evaluates a patient's beliefs about the potential dangers of physical activity and how those beliefs affect their willingness to move. The TSK has a 4-point Likert scale (strongly disagree to strongly agree) for each item. The total score can vary from 17 tot 68, with a higher score representing higher kinesiophobia.
Time frame: week 4, week 24
EQ-5D-5L
The EQ-5D-5L is a standardized instrument used to measure health-related quality of life. It consists of two parts: a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from "no problems" to "extreme problems" or "unable to". The EQ-VAS asks the respondent to rate their overall health on a scale of 0 to 100.
Time frame: week 0, week 4, week 12, week 24 Follow-up at week 52
Tegner Activity Scale (TAS)
The TAS is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes. Patients are asked to choose the highest level of activity they partake in at that moment.
Time frame: From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52
MRI: muscle volume
Based on MRI images, muscle volume will be calculated of plantarflexor muscles.
Time frame: week 4 and week 24 (pre- and post physical therapy)
MRI: fatty infiltration
Based on MRI images, fatty infiltration will be calculated
Time frame: week 4 and week 24 (pre- and post physical therapy)
Fear of rerupture
Yes/no question to assess fear of rerupture of the patient
Time frame: week 4, week 12, week 24 Follow-up at week 52
Unilateral drop jump test
The drop jump test is a plyometric exercise used to assess an athlete's reactive strength, specifically their ability to quickly transition from an eccentric (lengthening) muscle contraction during landing to a concentric (shortening) contraction during jumping, also including relevance of elastic energy storage in the tendon. It involves dropping from a predetermined height and immediately jumping as high as possible upon landing. The test measures the athlete's reactive strength index (RSI), which is calculated by dividing jump height by ground contact time.
Time frame: week 24, Follow-up at week 52
Unilateral counter movement jump
A unilateral countermovement jump (CMJ) is a jump test where an individual stands on one leg and performs a countermovement before jumping as high as possible, primarily assessing single-leg explosive power and interlimb asymmetries.
Time frame: week 24, Follow-up at week 52
International Physical Activity Questionnaire - Short form (IPAQ-SF)
IPAQ measures the time per week spent on walking, moderate or vigorous physical activity during different aspects of life (work, leisure, household tasks, etc.). The time active will be converted to Metabolic Equivalent of a task (MET)-minutes per week. The higher the MET value, the higher the energy expenditure/physical activity.
Time frame: week 0, week 4, week 8, week 12, week 18, week 24 Follow-up week 52
Tendon biopt histology
Histologic evaluation of tendon biopt which is collected during surgery: cellularity, cell roundness (morphology), collagen arrangement and ground substance (proteogylcans).
Time frame: week 0
Tendon biopt mRNA
mRNA sequencing on tendon biopt collected during surgery
Time frame: week 0
Plan to share: Undecided
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University Hospital, Ghent