Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Dizziness Handicap Inventory (DHI)
研究概览
简要总结
The main aim of this study is to evaluate the effect of vestibular rehabilitation and balance training on patients with dizziness and balance problems after traumatic brain injury.
详细描述
8 000 to 10 000 persons are admitted to hospitals in Norway with traumatic brain injury (TBI)annually. Dizziness and balance problems have an incidence of 30-80% in this population.
Studies show that dizziness and imbalance has the potential to restrict several aspects of personal and social life.
Vestibular rehabilitation (VR) is an accepted and effective treatment for dizziness and imbalance. However there is lack of evidence/knowledge about its effect on TBI patients.
The study is designed as a randomized controlled trial study (RCT). Patients aged 16-60 admitted to Oslo University Hospital with TBI and symptoms of dizziness and imbalance are included 8 weeks after the injury.
The intervention and control group will receive multidisciplinary assessment and evaluation. The intervention group will in addition receive group training and a home exercise program by physiotherapists. The intervention will consist of a individually adapted Vestibular Rehabilitation and balance program.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TBI patients enrolled at Oslo University Hospital.
- •persistent dizziness and/or balance problems 2 months post-injury.
- •functionally and cognitively able to attend a group training program with vestibular rehabilitation and balance training as the main focus.
排除标准
- •severe psychiatric disorder,
- •language problems,
- •cognitive dysfunction that makes self-report difficult,
- •extremity injuries,
- •not being able to walk.
研究组 & 干预措施
Multidisciplinary evaluation and VR
Vestibular rehabilitation and balance training. Twice a week for eight weeks.Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
干预措施: Multidisciplinary evaluation and VR (Other)
Multidisciplinary evaluation and no VR
Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
干预措施: Multidisciplinary evaluation (Other)
结局指标
主要结局
Dizziness Handicap Inventory (DHI)
时间窗: Up to 12 months post injury
The Dizziness Handicap Inventory (DHI) was developed to measure the self-perceived level of handicap associated with the symptom of dizziness (Jacobson, 1990). The DHI is a 25 item self-report questionnaire with 3 response levels: yes = 4, sometimes = 2, no = 0. The total score is obtained by summing the ordinal scale responses obtained from the 3 response levels (0-100, higher score indicates worse handicap) (Jacobson, 1990). The DHI has been translated into Norwegian and has demonstrated satisfactory measurement properties (Tamber, 2009).
次要结局
- High level mobility assessment tool for traumatic brain injury (HiMAT)(Up to 12 months post injury)
研究者
Ingerid Kleffelgård
Physical Therapist/ PhD student
Oslo University Hospital