Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Blood flow restriction training (smart-cuff pro device)

    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)

  • Standardised strength training

    Other intervention

    This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Conventional therapyActive comparator 1 intervention
Group B: Blood flow restriction groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Power doppler

Doppler signal for vascularisation

Time frame
week 4, week 8, week 12, week 18, week 24 Follow-up at week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.