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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:
Undergo standard surgical repair of the Achilles tendon
Be randomly assigned to a 24-week exercise therapy program-either with or without blood flow restriction (BFR)-starting four weeks post-surgery
Take part in follow-up assessments at weeks 4, 8, 12, 18, 24, and 52, which will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| US: tendon cross-sectional area | measured by ultrasound | week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52 |
| US: tendon length | Description: measured by ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah VanDen Berghe | Contact | +32471178728 | sarah.vandenberghe@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Arne Burssens, Professor | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University | Not yet recruiting | Ghent | East-Flanders | 9000 | Belgium |
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| Standardised strength training | Other | This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises. |
|
| week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52 |
| SWE: tendon stiffness | Tendon stiffness measured by Shear Wave Elastography, range 0-800kPa with higher kPa representing higher stiffness | week 4, week 8, week 12, week 18, week 24 Follow-up at week 52 |
| Power doppler | Doppler signal for vascularisation | week 4, week 8, week 12, week 18, week 24 Follow-up at week 52 |
| Heel rise endurance test | 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. | week 18, week 24 Follow-up at week 52 |
| Possibility to perform one heel rise | Physical test where the patient is assessed based on the ability to perform one heel rise. Yes/no | week 12 |
| Plantarflexion strength | Isokinetic strength test measured by dynamometry (Biodex) | week 18, week 24, Follow-up at week 52 |
| Tampa scale of kinesophobia (TSK) | 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. | week 4, week 24 |
| EQ-5D-5L | 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. | week 0, week 4, week 12, week 24 Follow-up at week 52 |
| Tegner Activity Scale (TAS) | 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. | From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52 |
| MRI: muscle volume | Based on MRI images, muscle volume will be calculated of plantarflexor muscles. | week 4 and week 24 (pre- and post physical therapy) |
| MRI: fatty infiltration | Based on MRI images, fatty infiltration will be calculated | week 4 and week 24 (pre- and post physical therapy) |
| Fear of rerupture | Yes/no question to assess fear of rerupture of the patient | week 4, week 12, week 24 Follow-up at week 52 |
| Unilateral drop jump test | 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. | week 24, Follow-up at week 52 |
| Unilateral counter movement jump | 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. | week 24, Follow-up at week 52 |
| International Physical Activity Questionnaire - Short form (IPAQ-SF) | 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. | week 0, week 4, week 8, week 12, week 18, week 24 Follow-up week 52 |
| Tendon biopt histology | Histologic evaluation of tendon biopt which is collected during surgery: cellularity, cell roundness (morphology), collagen arrangement and ground substance (proteogylcans). | week 0 |
| Tendon biopt mRNA | mRNA sequencing on tendon biopt collected during surgery | week 0 |
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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