Aquatic Therapy During Post-acute Intensive Neurorehabilitation in Patients With Severe Traumatic Brain Injury: a Preliminary Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Berg Balance Scale (BBS) at 1month
研究概览
简要总结
Traumatic brain injury (TBI) is an acquired insult to the brain from an external mechanical force. It is considered a major cause of mortality and of long-term disabilities in young adults, especially considering high-income countries.
The TBI can cause a wide range of temporary and/or permanent brain's dysfunctions that can involve physical, cognitive, behavioural and emotional functioning limiting everyday life and social activities and leading to a lowers quality of life.
a sequential preparatory approach (SPA), performed in aquatic environment, based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex) could be an effective complementary training during post-acute intensive rehabilitation in patients with severe traumatic brain injury (sTBI).
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 15 and 65 years;
- •Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury)
- •level of cognitive functioning (LCF) ≥7;
- •ability to understand verbal commands.
- •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).
研究组 & 干预措施
Conventional
干预措施: Conventional Training (Other)
Sequential Preparotory Approach
干预措施: Aquatic Training (Other)
结局指标
主要结局
Change in Berg Balance Scale (BBS) at 1month
时间窗: 1 month
Change of Berg Balance Scale (BBS) from baseline at 1 month. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest
次要结局
- Modified Barthel Index (MBI)(baseline and after 4 weeks of training)
- Change in quality of life assessed by the proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI)(baseline and after 4 weeks of training)
- Modified Ashworth Scale (MAS)(baseline and after 4 weeks of training)
- Tinetti Balance and Gait Scale (TBG)(baseline and after 4 weeks of training)
- Disability Rating Scale (DRS)(baseline and after 4 weeks of training)
研究者
Marco Tramontano
head of rehabilitation Services
I.R.C.C.S. Fondazione Santa Lucia