Visual Feedback in Lower Limb Rehabilitation: the Alpha and the OMEGO®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change of Symmetry after the performance of the motor task
研究概览
简要总结
Severe Acquired Brain Injury (sABI) is defined as "an encephalic impairment that occurs after birth and is not related to a congenital or degenerative disease.
This impairment may be temporary, or permanent, and cause partial or functional disability or psychosocial distress." In Italy there are at least 10-15 new cases of sABI per year per 100,000 inhabitants; the estimated prevalence is about 150,000 cases per year. Often, people with sABI present focal neurological deficits, including alterations in strength, sensitivity, coordination and gait.
Most of the rehabilitation protocols for people with sABI are derived from post-stroke studies, caused by lack of evidence on specific rehabilitation of people with sABI. Rehabilitation of people with sABI should begin as soon as possible, to prevent the onset of retractions and decubitus, and to regain joint mobility, strength, and coordination.
OMEGO® (Tyromotion) is a newly developed device used in lower extremity rehabilitation, that provides visual and auditory feedback.
Specifically, OMEGO® contains several games developed to enhance and promote learning behaviors, that simulate activities of daily living. The use of devices such as cycle ergometers is recommended in the rehabilitation of people with sABI; however, there are no studies demonstrating the effect of cycle ergometer training in association with visual feedback.
The purpose of this study is to evaluate, both in people without apparent pathology (hereafter identified as "healthy") and in people with sABI, whether visual feedback during OMEGO® exercise modifies brain connectivity, emotional drive, and lower limb performance during a lower limb-specific motor rehabilitation task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis os severe Acquired Brain Injury (sABI)
- •Trunk Control Test score greater or equal to 48
- •Motricity Index Lower Limb score greater or equal to 18
- •Clinical stability
- •Patient/Caregiver ability to understand ans sing the informed consent
排除标准
- •Disorder of consciousness (mininally concious state or vegetative state)
- •severe visual impairment (central or peripheral, prior or acquired after the scute event)
- •presence of severe cognitive impairment
- •presence of global aphasia or presence of severe apraxia
结局指标
主要结局
Change of Symmetry after the performance of the motor task
时间窗: Change from baseline at T4 [after 18 minutes]
The symmetry between lower limbs will be evaluated, comparing the percentage of movement between limbs.
次要结局
- Change of Proprioception(Change from baseline at T4 [after 18 minutes])
- Brain connectivity(Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4])
- Electrodermal activity(Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4])
- Heart Rate Variability(Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4])
研究者
PADUA LUCA
Associated Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS