NCT01329705撤回不适用
Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in gait pattern
研究概览
简要总结
The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled will be male or female, be at least 18 years of age, and have been diagnosed with spastic hemiplegia and excessive plantarflexion, which includes the following:
- •Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study
- •Reduced AROM and PROM in ankle dorsiflexion
- •Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)
- •Inability to ambulate with initial heel-contact
- •No prior BTX treatment within 6 months
- •R1 of -10° or greater (using the Tardeiu method of assessment)
- •Mean Ashworth Scale Test ≥3 for plantarflexors
排除标准
- •Bell's Palsy
- •Viral Encephalitis
- •Muscular Dystrophy
- •Multiple Sclerosis
- •Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle
- •Subjects with a fixed contracture of the ankle
- •Female subjects who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or are of childbearing potential and do not practice a reliable method of birth control
- •Bleeding disorders
- •Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)
- •Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function
- •Subjects with profound weakness or atrophy of the muscles in the target areas of injection
- •Active systemic infection or infection at the injection site
- •Allergy or sensitivity to botulinum toxin A
研究组 & 干预措施
Control
Active Comparator
All patients will be treated with the current standard of care including onabotulinum toxin
干预措施: Standard of care (Other)
Dynasplint
Experimental
Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint
干预措施: Ankle Dorsiflexion Dynasplint (Device)
结局指标
主要结局
Change in gait pattern
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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