"Feasibility and Efficacy of Virtual Reality With Xbox Kinect in the Rehabilitation of Cronic Traumatic Brain Injuries: a Randomized Controlled Trial".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change from baseline in balance with Community Balance & Mobility Scale (CB&M)
研究概览
简要总结
Traumatic brain injury is an extremely common disease, it counts 50.000 deaths and 235.000 hospitalizations every year. Functional consequences of an acquired brain injury have a considerable impact on quality of lives of patients and care-givers with direct effects on balance, mobility and on psycho-social functions. Attention deficits are one of the most frequent and disabling consequences of severe brain injury. Within the wide spectrum of attentive problems, patients with traumatic brain injury frequently have shown difficulties in divided attention. Patients, care-givers and professionals frequently refer difficulties also in selective attention and vigilance as consequence of the trauma. It has been shown how these difficulties are tightly related with the missed return to work after two years from the injury.
The hypothesis of this study is to investigate the feasibility of a rehabilitative protocol on gaming using the console Xbox and its efficacy in improving balance, mobility, risk of falling, attentive functions (selective and divided attention) in subjects which have had a traumatic brain injury at least 12 months before.
详细描述
Inclusion Criteria:
Chronic traumatic brain injury (>12 months) Age>18, <70 years old Presence of a moderate balance deficit identified by CB&M with a score < 65 or presence of a selective attention and shifting attention deficit identified by the TEA computerized battery (Tau<37).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic traumatic brain injury (>12 months)
- •Age>18, <70 years old
- •Presence of a moderate balance deficit identified by UBS with a score>15 and < 60 or presence of a selective attention and shifting attention deficit identified by the TEA computerized battery (Tau<37).
排除标准
- •Neurologic diseases associated with possible involvement of motor functions
- •Medical conditions that could interfere with the safe conclusion of the study protocol
- •Severe cognitive-behavioural diseases (LCF<6),
- •severe psychiatric diseases
- •Use of walking aids
结局指标
主要结局
Change from baseline in balance with Community Balance & Mobility Scale (CB&M)
时间窗: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
次要结局
- Participation Objective, Participation Subjective Scale(POPS)(1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.)
- Attentive functions evaluation Attentive functions evaluation(1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.)
- postural sway(1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.)
- Timed Up and Go (TUG)(1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.)
- Unified Balance Scale (UBS)(1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.)
研究者
Sofia Straudi, MD
Physical Medicine and Rehabilitation doctor
University Hospital of Ferrara