Effects of Vestibular Rehabilitation in Patients With Severe Traumatic Brain Injury: 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
- 30
- 试验地点
- 4
- 主要终点
- Dynamic Gait Index Scoring Form (DGI)
研究概览
简要总结
Severe brain injury (sTBI) is one of the most common causes of long-term disability and is considered the most frequent cause of mortality and serious disability in young adults in industrialized countries. It is defined as an alteration of brain function with loss of consciousness in the acute phase for at least 24 hours (Glasgow Coma Scale (GCS) <8) and it can induce a wide range of deficit, including cognitive-behavioural, motors, psychics, language, vision, coordination and balance impairments. Chronic vestibular symptoms such as dizziness and balance deficits (both static and dynamic postural instability) are present in patients with brain injury. These aspects can cause functions limitation and psychological distress, negatively impacting negatively on subjects' quality of life and social reintegration and are considered unfavourable prognostic factors of the recovery process. The literature supports the use of vestibular rehabilitation techniques in patients with mild and moderate brain injury, however, to date, no studies investigated the effect of vestibular rehabilitation in sTBI patients. The main aim of this randomized controlled trail is to verify the effect of a personalized vestibular training on balance and gait disorders in sTBI patients.
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 and the informed consent.
- •Presence of static and dynamic balance impairments.
- •Functional Ambulation Classification (FAC) ≥ 3
排除标准
- •Glasgow coma scale (GCS) score >8
- •Level of cognitive functioning (LCF) <7
- •Inability to understand verbal commands
- •Absence of static and dynamic balance impairments.
- •Functional Ambulation Classification (FAC) < 3
结局指标
主要结局
Dynamic Gait Index Scoring Form (DGI)
时间窗: Baseline to 8 weeks after the end training
Change of Dynamic Gait Index Scoring Form (DGI) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. DGI values ranging from 0 to 24, where 0 means the worse outcome and 24 the best one.
次要结局
- Activities-specific Balance Confidence scale (ABC)(Baseline to 8 weeks after the end training)
- Community Balance & Mobility Scale (CB&M)(Baseline to 8 weeks after the end training)
- Community Integration Questionnaire (CIQ)(Baseline to 8 weeks after the end training)
- Berg Balance Scale (BBS)(Baseline to 8 weeks after the end training)
- Dizziness Handicap Inventory (DHI)(Baseline to 8 weeks after the end training)
- Instrumental Assessment(Baseline to 8 weeks after the end training)
研究者
Marco Tramontano
head of rehabilitation Services
I.R.C.C.S. Fondazione Santa Lucia