Effects of Mirror Therapy and Cognitive Therapeutic Exercise on Improvements to the Upper Member Functions of Stroke Patients: a Randomized Clinical Test Study Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Functionality of the affected upper member.
研究概览
简要总结
This is a randomized clinical trial aimed at patients with a diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke. Its objective is to evaluate the effects of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, to achieve maximum functionality of the affected upper member,
详细描述
Objective
To assess the effect at 3 months of the of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, applied for 30 days in the functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and quality of life in stroke patients.
Design and setting: A randomized clinical trial of three parallel groups.
Population: 152 patients with residual hemiparesis due to ischemic or hemorrhagic stroke will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the University Hospital of Burgos (HUBU).
Measurements and intervention: Functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and health-related quality of life will be evaluated. The intervention groups will receive a treatment based either on mirror therapy or on congnitive therapeutic exercise, both combined with task-oriented motor learning for 30 days. No additional intervention with the participants of the control group will be completed.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke,
- •Movements of the affected upper members classified between stages II and IV on the Brunnstrom Scale
- •Score on the Montreal Cognitive Assessment (MOCA) scale equal to or over 26
排除标准
- •Heminegligence
- •Wernicke's aphasia
- •Visual deficits (homonymous hemianopsia)
研究组 & 干预措施
Mirror therapy group
The mirror therapy group will receive a treatment based on this therapy, combined with task-oriented motor learning.
干预措施: Mirror therapy (Behavioral)
Cognitive therapeutic exercise group
The cognitive therapeutic exercise group will receive a treatment based on this therapy, combined with task-oriented motor learning.
干预措施: Cognitive therapeutic exercise (Behavioral)
Control Group
No additional intervention with the participants of this group will be completed.
结局指标
主要结局
Functionality of the affected upper member.
时间窗: 3 months
Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)
次要结局
- Spasticity of the upper member(3 months)
- Cognitive performance.(3 months)
- Emotional state and quality of life.(3 months)
- Basic Daily Living Activities(3 months)
- Instrumental activities of daily living(3 months)