Effects of Neuropilates on Rehabilitation Programs for Chronic Stroke: A Randomized Clinical Trial

Universidad Rey Juan Carlos2 个研究点分布在 1 个国家目标入组 30 人开始时间: 2023年7月1日最近更新: 2023年11月13日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Universidad Rey Juan Carlos
入组人数: 30
试验地点: 2
主要终点: Functional Independance Measure (FIM)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Introduction: Cerebrovascular damage (stroke) can generate motor or cognitive sequelae, making rehabilitation (such as the Pilates method) necessary to improve autonomy and quality of life. However, there are no studies on the efficacy of the method in the recovery of the upper limb and the improvement of autonomy after stroke.

Methods: Randomized double-blind clinical trial with patients with stroke in semi-acute period, randomized into experimental group (EG) (conventional rehabilitation and Pilates) or control group (CG) (conventional rehabilitation).

After randomization and initial evaluation, the intervention will begin (2 sessions per week, 3 months). After completion, there will be post-intervention assessment, and another one at 1 month.

Intervention: The CG will receive 30 minutes of physical therapy and 30 minutes of occupational therapy. The SG will receive 20 minutes of physiotherapy, 20 minutes of occupational therapy and 20 minutes of Pilates.

Assessment instruments: Mean Functional Independence; Functional Range Test; Timed 'Up and Go'; Nine Hole Peg Test; Box and Block Test; Arm, Shoulder and Hand Disabilities Questionnaire; Client Satisfaction Questionnaire.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•present a diagnosis of ischemic or hemorrhagic stroke with a minimum evolution of 3 months;
•be over 18 years of age;
•regularly attend rehabilitation treatment at the Physiocare Madrid center;
•present moderate functional problems (score greater than 65 on the Barthel Index);
•not present moderate cognitive impairment (Mini Mental State Examination less than 18 points);
•not present nasogastric tubes;
•accept to participate voluntarily in the study and sign the informed consent form;
•be able to participate in the study and sign the informed consent form.

排除标准

•time of evolution of less than 3 months;
•other conditions of the central nervous system (tumors, anoxia, cranioencephalic trauma, etc.);
•cardiorespiratory or neurodegenerative disorders, severe brain damage or a score of 6 or higher on the Reisberg Deterioration Scale (GDS);
•a severely impaired level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
•receiving other complementary rehabilitative therapy;
•a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
•a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
•a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS).