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
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1) Primary outcome parameters measured by 3DfUS muscle volume.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants eligible for inclusion in this Trial must meet all of the following criteria
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- •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.
- •Pes equinovarus due to spasticity
- •Clinical need for BoNT injection at the lower leg
- •Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago
- •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
- •Profound atrophy of the muscles in the target area(s) of injection
结局指标
主要结局
1) Primary outcome parameters measured by 3DfUS muscle volume.
1) Primary outcome parameters measured by 3DfUS muscle volume.
2) Primary outcome parameters measured by ISA The primary outcome parameter to determine the neural contributions to hyperresistance will be derived from the fast stretch: muscle activity (root mean square (RMS) EMG [uV].
2) Primary outcome parameters measured by ISA The primary outcome parameter to determine the neural contributions to hyperresistance will be derived from the fast stretch: muscle activity (root mean square (RMS) EMG [uV].
次要结局
未报告次要终点
研究者
Ethische commissie onderzoek
Scientific
UZ Leuven