Exploratory, Longitudinal Study to Define Changes in Muscle, Tendon and Neural Properties After Botuline Neurotoxin Type A (BoNT) Treatment of Spastic Equinovarus in First-ever Stroke Patients: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- sample size calculation
研究概览
简要总结
Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Treatment outcomes and long-term responses to interventions can vary significantly between individual patients. Additionally, there is increasing concern about potential adverse effects on muscle morphology. Further research is essential to optimize treatment strategies and improve long-term outcomes in this population. Three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) are two recently developed techniques that enable the evaluation of changes in muscle, tendon, and neural properties following BoNT injections for post-stroke spastic equinovarus. These methods hold promise for providing new insights into treatment effects. Before implementing these techniques in large-scale studies, a pilot study is required for accurate sample size calculations for a prospective observational study. This study includes a protocol for a non-blinded, non-randomized open-label longitudinal pilot study. The study was approved by the European Medicines Agency ( EU CT Number 2024-513158-32) by the University Hospitals Leuven ethical committee (ID S68672). Standard deviations and effect sizes of outcome measures obtained longitudinally with 3DfUS and ISA before and after BoNT injection into MG will inform sample size calculations for future research.
详细描述
TRIAL RATIONALE:
To conduct a pilot study as guidance for a future observational study to evaluate changes in muscle, tendon and neural properties after botulinum neurotoxin-A (BoNT) treatment of spastic equinovarus in first-ever stroke patients by using Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA) with the aim of optimizing treatment algorithms and long-term response in this population.
TRIAL DESIGN:
Non-blinded, non-randomized open label, longitudinal pilot interventional clinical trial.
In total, 4 visits will be organised:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- •3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- •4. Pes equinovarus due to spasticity
- •5. Clinical need for BoNT injection at the lower leg
- •6. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago
- •7. First-ever, unilateral stroke
排除标准
- •Musculoskeletal or other neurological problems affecting the lower limb
- •Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
- •Cognitive problems that impede measurements
- •Severe co-morbidities
- •Irritated skin or open wounds where ultrasound will be placed
- •Pregnancy
- •Profound atrophy of the muscles in the target area(s) of injection
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- •The effect of botulinum toxin A can theoretically be potentiated by agents affecting neuromuscular transmission, such as aminoglycoside antibiotics (e.g., gentamicin, tobramycin), lithium salts, cholinesterase inhibitors and tubocurarine-like muscle relaxants ((cis)atracurium, rocuronium, suxamethonium, vecuronium). Therefore, patients on whom these medications are started during the course of the trail will be excluded.
研究组 & 干预措施
stroke patients treated with Botulinum toxine injections for spastic equinovarus
This study involves a single-arm, exploratory, longitudinal design focusing on first-time stroke patients with spastic equinovarus deformity. Participants will receive Botulinum Neurotoxin Type A (BoNT-A) injections targeting medial and lateral gastrocnemius muscle as well ass soleus muscle. The intervention aims to assess changes in muscle, tendon, and neural properties before and after treatment by using instrumented spasticity assessment and threedimensional freehand ultrasound
干预措施: threedimensional freehand ultrasound and instrumented spasticity assessment (Diagnostic Test)
结局指标
主要结局
sample size calculation
时间窗: 2 years
To estimate the number of subjects to calculate an appropriate sample size for assessing changes in muscle, tendon and neural properties after BoNT treatment of spastic equinovarus in first-ever stroke patients by using 3DfUS and ISA in a future observational study. To calculate standard deviation and effect sizes of outcome measures obtained with 3DfUS and ISA in these patients.
次要结局
- muscle changes(2 years)
- neural changes(2 years)
- functional changes(2 years)