Achilles Tendon Rupture, Blood Flow Restriction Therapy
Conditions
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: 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
DEVICEBlood 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)
OTHERStandardised strength training
This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achilles tendon rupture score (ATRS) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| US: tendon cross-sectional area | week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52 | measured by ultrasound |
| US: tendon length | week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52 | Description: measured by ultrasound |
| SWE: tendon stiffness | week 4, week 8, week 12, week 18, week 24 Follow-up at week 52 | Tendon stiffness measured by Shear Wave Elastography, range 0-800kPa with higher kPa representing higher stiffness |
| Power doppler | week 4, week 8, week 12, week 18, week 24 Follow-up at week 52 | Doppler signal for vascularisation |
| Heel rise endurance test | week 18, week 24 Follow-up at week 52 | The Heel Rise Endurance Test (HRET) is a functional assessment used to evaluate calf muscle endurance and strength following an Achilles tendon rupture. It involves repeatedly raising up onto the toes (heel raises) on one leg until exhaustion, with the number of repetitions recorded as a measure of performance. This test helps quantify the recovery of plantar flexion strength and endurance after injury. Combined with a linear encoder, also heel rise height and work is calculated. |
| Possibility to perform one heel rise | week 12 | Physical test where the patient is assessed based on the ability to perform one heel rise. Yes/no |
| Tampa scale of kinesophobia (TSK) | week 4, week 24 | The Tampa Scale for Kinesiophobia (TSK) is a 17-item self-report questionnaire used to assess fear of movement or re-injury (kinesiophobia) in individuals, particularly those with musculoskeletal pain. It evaluates a patient's beliefs about the potential dangers of physical activity and how those beliefs affect their willingness to move. The TSK has a 4-point Likert scale (strongly disagree to strongly agree) for each item. The total score can vary from 17 tot 68, with a higher score representing higher kinesiophobia. |
| EQ-5D-5L | week 0, week 4, week 12, week 24 Follow-up at week 52 | The EQ-5D-5L is a standardized instrument used to measure health-related quality of life. It consists of two parts: a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from no problems to extreme problems or unable to. The EQ-VAS asks the respondent to rate their overall health on a scale of 0 to 100. |
| Plantarflexion strength | week 18, week 24, Follow-up at week 52 | Isokinetic strength test measured by dynamometry (Biodex) |
| MRI: muscle volume | week 4 and week 24 (pre- and post physical therapy) | Based on MRI images, muscle volume will be calculated of plantarflexor muscles. |
| MRI: fatty infiltration | week 4 and week 24 (pre- and post physical therapy) | Based on MRI images, fatty infiltration will be calculated |
| Fear of rerupture | week 4, week 12, week 24 Follow-up at week 52 | Yes/no question to assess fear of rerupture of the patient |
| Unilateral drop jump test | week 24, Follow-up at week 52 | The drop jump test is a plyometric exercise used to assess an athlete's reactive strength, specifically their ability to quickly transition from an eccentric (lengthening) muscle contraction during landing to a concentric (shortening) contraction during jumping, also including relevance of elastic energy storage in the tendon. It involves dropping from a predetermined height and immediately jumping as high as possible upon landing. The test measures the athlete's reactive strength index (RSI), which is calculated by dividing jump height by ground contact time. |
| Unilateral counter movement jump | week 24, Follow-up at week 52 | A unilateral countermovement jump (CMJ) is a jump test where an individual stands on one leg and performs a countermovement before jumping as high as possible, primarily assessing single-leg explosive power and interlimb asymmetries. |
| International Physical Activity Questionnaire - Short form (IPAQ-SF) | week 0, week 4, week 8, week 12, week 18, week 24 Follow-up week 52 | IPAQ measures the time per week spent on walking, moderate or vigorous physical activity during different aspects of life (work, leisure, household tasks, etc.). The time active will be converted to Metabolic Equivalent of a task (MET)-minutes per week. The higher the MET value, the higher the energy expenditure/physical activity. |
| Tendon biopt histology | week 0 | Histologic evaluation of tendon biopt which is collected during surgery: cellularity, cell roundness (morphology), collagen arrangement and ground substance (proteogylcans). |
| Tendon biopt mRNA | week 0 | mRNA sequencing on tendon biopt collected during surgery |
| Tegner Activity Scale (TAS) | From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52 | The TAS is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes. Patients are asked to choose the highest level of activity they partake in at that moment. |
Countries
Belgium
Contacts
Primary ContactSarah VanDen Berghe
Outcome results
None listed