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

NCT07131787 | Recruiting DMC FDA Device

• 1 other identifier: ONZ-2025-0152
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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:

• 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

Outcome Measures

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.

  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 (18)

• US: tendon cross-sectional area

  week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52

• US: tendon length

  week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52

• SWE: tendon stiffness

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

• Power doppler

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

• Heel rise endurance test

  week 18, week 24 Follow-up at week 52

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

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

Blood flow restriction group

EXPERIMENTAL

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)

Interventions

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)

Also known as: Kaatsu, Partial vascular occlusion

Blood flow restriction group

Standardised strength training OTHER

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

Conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Ghent University

Ghent, East-Flanders, 9000, Belgium

NOT YET RECRUITING

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Arne Burssens, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah VanDen Berghe

CONTACT

+32471178728; sarah.vandenberghe@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 20, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-04

Locations

BE (2)