Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery
NCT07131787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2025-09-23
Summary
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
Conditions
- Achilles Tendon Rupture
- Blood Flow Restriction Therapy
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.
Sponsors & Collaborators
-
University Hospital, Ghent
lead OTHER
Principal Investigators
-
Arne Burssens, Professor · University Ghent
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-20
- Primary Completion
- 2028-05-31
- Completion
- 2028-11-30
- FDA Device
- Yes
Countries
- Belgium
Study Locations
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