About this trial
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:
1. Undergo standard surgical repair of the Achilles tendon 2. Be randomly assigned to a 24-week exercise therapy program-either with or without blood flow restriction (BFR)-starting four weeks post-surgery 3. Take part in follow-up assessments at weeks 4, 8, 12, 18, 24, and 52, which will include:
* Questionnaires on pain, quality of life, fear of movement, and return to sport * Medical imaging techniques such as ultrasound, MRI, shear wave elastography, and power Doppler * Muscle strength testing * Blood sample collection, along with a tendon tissue sample taken during surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with total midrupture Achilles tendon rupture
surgical treatment
> 18 years old
able to understand and speak Dutch
Disqualifiers
Bilateral Achilles tendon rupture
Previous Achilles tendon rupture
Previous treatment with fluoroquinolones or cortisone
other condition in either leg that would limit the ability to perform the exercises or evaluations
Trial design
Parallel
Treatments tested in this trial
Blood flow restriction training (smart-cuff pro device)
DeviceThis 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)
Standardised strength training
Other interventionThis group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
US: tendon cross-sectional area
measured by ultrasound
US: tendon length
Description: measured by ultrasound
SWE: tendon stiffness
Tendon stiffness measured by Shear Wave Elastography, range 0-800kPa with higher kPa representing higher stiffness
Power doppler
Doppler signal for vascularisation
Sponsors and contacts
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