Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Timed 25-foot Walk Test
研究概览
简要总结
There are limited but encouraging results supporting the use of dalfampridine in patients with hereditary spastic paraplegia. The investigators aimed to investigate the effects of dalfampridine on walking speed, muscle length, spasticity, functional strength, and functional mobility in patients with hereditary spastic paraplegia. In this triple-blinded, randomized, placebo-controlled trial, 4 patients with hereditary spastic paraplegia received dalfampridine (10 mg twice daily) plus physiotherapy (2 times per week), and 4 patients received placebo plus physiotherapy for a total duration of 8 weeks. The assessor and treating physiotherapists, and patients were masked to the group allocation. The primary outcome was Timed 25-foot Walk Test at the end of the 8-week treatment. The secondary outcome measures were functional mobility, functional muscle strength, muscle length, and spasticity.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Hereditary Spastic Paraplegia at least 1 year ago
排除标准
- •Having another neurological disorder
- •An orthopedic deformity in the lower extremity
- •Having a serious cognitive impairment
研究组 & 干预措施
Medication
Dalfampridine plus physiotherapy
干预措施: Dalfampridine 10 MG (Drug)
Medication
Dalfampridine plus physiotherapy
干预措施: Physiotherapy (Behavioral)
No Medication
Placebo plus physiotherapy
干预措施: Placebo (Drug)
No Medication
Placebo plus physiotherapy
干预措施: Physiotherapy (Behavioral)
结局指标
主要结局
Timed 25-foot Walk Test
时间窗: Change from baseline to week 8
The Timed 25-foot walk test (T25FW) is considered the "best characterized objective measure of walking disability and can be used across a wide range of walking disabilities". For the T25-FW, patients were instructed to walk as fast as they could in a safemanner along amarked 25-foot course. The time in seconds to complete each test was recorded, and the test was immediately repeated.
次要结局
- Sit to Stand Test(Change from baseline to week 8)
- Timed Up and Go test(Change from baseline to week 8)
- Modified Ashworth Scale(Change from baseline to week 8)
- Muscle Length Measurement(Change from baseline to week 8)
研究者
Ferda Selcuk
Assist Prof. Dr.
European University of Lefke