Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Achilles tendon rupture score (ATRS)
研究概览
简要总结
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:
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with total midrupture Achilles tendon rupture
- •surgical treatment
- •> 18 years old
- •able to understand and speak Dutch
排除标准
- •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
研究组 & 干预措施
Conventional therapy
control group: patients in this group will undergo the same standard strength training program as the BFR-group, but without a tourniquet.
干预措施: Standardised strength training (Other)
Blood flow restriction group
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.
干预措施: Blood flow restriction training (smart-cuff pro device) (Device)
结局指标
主要结局
Achilles tendon rupture score (ATRS)
时间窗: 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.
次要结局
- 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)
- Possibility to perform one heel rise(week 12)
- Plantarflexion strength(week 18, week 24, Follow-up at week 52)
- Tampa scale of kinesophobia (TSK)(week 4, week 24)
- EQ-5D-5L(week 0, week 4, week 12, week 24 Follow-up at week 52)
- Tegner Activity Scale (TAS)(From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52)
- MRI: muscle volume(week 4 and week 24 (pre- and post physical therapy))
- MRI: fatty infiltration(week 4 and week 24 (pre- and post physical therapy))
- Fear of rerupture(week 4, week 12, week 24 Follow-up at week 52)
- Unilateral drop jump test(week 24, Follow-up at week 52)
- Unilateral counter movement jump(week 24, Follow-up at week 52)
- International Physical Activity Questionnaire - Short form (IPAQ-SF)(week 0, week 4, week 8, week 12, week 18, week 24 Follow-up week 52)
- Tendon biopt histology(week 0)
- Tendon biopt mRNA(week 0)
- Tendon biopt mRNA(week 0)
- 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)
- Possibility to perform one heel rise(week 12)
- Plantarflexion strength(week 18, week 24, Follow-up at week 52)
- Tampa scale of kinesophobia (TSK)(week 4, week 24)
- EQ-5D-5L(week 0, week 4, week 12, week 24 Follow-up at week 52)
- Tegner Activity Scale (TAS)(From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52)
- MRI: muscle volume(week 4 and week 24 (pre- and post physical therapy))
- MRI: fatty infiltration(week 4 and week 24 (pre- and post physical therapy))
- Fear of rerupture(week 4, week 12, week 24 Follow-up at week 52)
- Unilateral drop jump test(week 24, Follow-up at week 52)
- Unilateral counter movement jump(week 24, Follow-up at week 52)
- International Physical Activity Questionnaire - Short form (IPAQ-SF)(week 0, week 4, week 8, week 12, week 18, week 24 Follow-up week 52)
- Tendon biopt histology(week 0)