A Water-based Sequential Preparatory Approach Versus Conventional Aquatic Training in Stroke Patients: a Randomized Controlled Trial With a One-month Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Berg Balance Scale at 2 months
研究概览
简要总结
Many studies hypothesize that people who have suffered stroke could benefit from water-based exercises to improve their strength and ability to perform the activities of daily living.
A Cochrane Review systematically synthesized and compared the effects of aquatic and land-based therapies on the activities of daily living (ADL) of patients following stroke and found that water-based exercises improved strength and ADL. A recent review indicates that RCTs comparing aquatic methods in both environments are lacking. The same movements in water and on dry land that target postural stability and gait require different competences. For example, the postural instability that occurs while squatting in water was enacted on land by sitting on a therapy ball. Furthermore, land-based conventional rehabilitation is generally task oriented, customized and challenging and follows a specific preparatory sequence of exercises according to patients' disabilities. Therefore, the investigators believe that a sequential preparatory approach (SPA), based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex), should also be used in an aquatic environment.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke with unilateral hemiplegia within the previous six months;
- •Ability to walk without any device or need of continuous physical assistance to support body weight or maintain balance (Functional Ambulation Classification ≥ 3);
- •Acclimatization to water.
排除标准
- •Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination > 24);
- •Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);
- •Severe aphasia (diagnosed by means of neuropsychological assessment);
- •Presence of other neurological diseases;
- •Presence of cutaneous and mycosis infections;
- •Presence of open wounds, eczema, skin ulcers, decubitus lesions, severe burns;
- •Presence of PEG (Percutaneous endoscopic gastrostomy);
- •Presence of tracheostomy;
- •Urinary incontinence;
- •Presence of otitis
- •Presence of orthopedic or cardiac comorbidities that would limit participation in the experimental and conventional training (all of which were clinically evaluated).
结局指标
主要结局
Change in Berg Balance Scale at 2 months
时间窗: at 2 months
Change of Berg Balance Scale (BBS) from baseline at 2 months. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest
次要结局
- Stroke Specific Quality Of Life Scale (SS-QOL)(baseline, after 4 weeks of training, and 4 weeks after the end of training)
- Modified Barthel Index (MBI)(baseline, after 4 weeks of training, and 4 weeks after the end of training)
- Tinetti Balance and Gait Scale (TBG)(baseline, after 4 weeks of training, and 4 weeks after the end of training)
- Modified Ashworth Scale (MAS)(baseline, after 4 weeks of training, and 4 weeks after the end of training)
研究者
Marco Tramontano
Head of Rehabilitation Services
I.R.C.C.S. Fondazione Santa Lucia