NCT03549975已完成4 期
Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study
National Rehabilitation Center, Seoul, Korea0 个研究点目标入组 20 人开始时间: 2016年5月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Change in Box and Block test
研究概览
简要总结
The investigator tried to find out possibility of functional improvement using botulinum toxin injection targeting finger flexor spasticity with functional electrical stimulation among chronic stroke patients who did not show any improvement in hand function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years
- •hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke
- •fingers and wrist flexor spasticity graded at least 1+ on the Modified Ashworth Scale
- •at least 6 months since stroke
排除标准
- •fixed contracture
- •previous treatment of the upper limb spasticity with neurolytic or surgical procedure
- •treatment with botulinum toxin type A in the previous 4 months
- •any active device implant
- •any neurological disorder, other than stroke causing motor deficits or spasticity
- •inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia
- •pregnancy, planned pregnancy, or lactation
- •contraindication to botulinum toxin type A
研究组 & 干预措施
Botulinum toxin type A injection
Experimental
Botulinum toxin type A injection followed by functional electrical stimulation
干预措施: Botulinum Toxin Type A 100 unit/Vial (Product) (Drug)
结局指标
主要结局
Change in Box and Block test
时间窗: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
number of box moved by affected upper extremity
Change of Action Research Arm Test
时间窗: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Score of Action Research Arm Test
次要结局
- Muscle strength of finger extensor(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Spasticity of finger extensor(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Brunnstrom stage of stroke recovery of distal upper extremity(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Repeated number of finger extension and flexion(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- active range of motion of wrist joint(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Distance from middle finger tip to mid-palmar crease(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Grading of active thumb opposition(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Grip strength(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Quick Disabilities of Arm, Shoulder & Hand(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Active finger extension(baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
研究者
Joon-Ho Shin
Team manager of Department of Neurorehabilitation
National Rehabilitation Center, Seoul, Korea
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