Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- The primary outcome assessed spasticity on the Modified Ashworth Scale.
研究概览
简要总结
Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.
详细描述
Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT)are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. To date, only a single case report addressed this issue. Theoretically, application of a mCIMT program with intensive functional tasks practice after spasticity reduction by BtxA may improve affected upper extremity function in patients with poststroke spasticity. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 80 years
- •at least 1 year after a unilateral stroke
- •modified ashworth scale (MAS) score > 3 in the elbow, wrist or finger flexors
- •ability to actively extend > 10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb (minimal motor criteria).
排除标准
- •presence of fixed joint contractures
- •serious balance problems
- •preexisting neurological deficits, neuromuscular diseases or uncontrolled medical conditions
- •significant cognitive deficits (Mini-Mental Status Examination score < 24)
- •excessive pain in the affected upper limb
- •previous treatment with Botulinum toxin A, neurolytic agents or surgery for spasticity
- •All patients were not currently participating in any experimental studies and did not receive concomitant oral anti-spastic medication during the study period
结局指标
主要结局
The primary outcome assessed spasticity on the Modified Ashworth Scale.
时间窗: MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.
次要结局
- Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction.(evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.)