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Recruiting NCT07131787

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

No phase Interventional Achilles Tendon Rupture Blood Flow Restriction Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood flow restriction training (smart-cuff pro device), Standardised strength training.
Who it may be relevant to
Registry conditions: Achilles Tendon Rupture, Blood Flow Restriction Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

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

Primary outcome measures

  • Achilles tendon rupture score (ATRS) [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 outcome measures (12)
  • US: tendon cross-sectional area [Time frame: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52]
  • US: tendon length [Time frame: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52]
  • SWE: tendon stiffness [Time frame: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52]
  • Power doppler [Time frame: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52]
  • Heel rise endurance test [Time frame: week 18, week 24 Follow-up at week 52]
  • Possibility to perform one heel rise [Time frame: week 12]
  • Plantarflexion strength [Time frame: week 18, week 24, Follow-up at week 52]
  • Tampa scale of kinesophobia (TSK) [Time frame: week 4, week 24]
  • EQ-5D-5L [Time frame: week 0, week 4, week 12, week 24 Follow-up at week 52]
  • Tegner Activity Scale (TAS) [Time frame: From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52]
  • MRI: muscle volume [Time frame: week 4 and week 24 (pre- and post physical therapy)]
  • MRI: fatty infiltration [Time frame: week 4 and week 24 (pre- and post physical therapy)]

Eligibility criteria

Inclusion criteria

  • patients with total midrupture Achilles tendon rupture
  • surgical treatment
  • > 18 years old
  • able to understand and speak Dutch

Exclusion criteria

  • 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
  • Diabetes or rheumatic diseases
  • History of deep venous thrombosis
  • severe cardiovascular disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Belgium · 2 centers
  • Ghent University — Ghent
  • Ghent University Hospital — Ghent

Identifiers

NCT: NCT07131787 · ONZ-2025-0152

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗