Virtual Reality Based Rehabilitation of Vestibular and Oculomotor Function for Pediatric ABI in a Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pediatric Vestibular Symptom Questionnaire (PVSQ)
研究概览
简要总结
The primary objective of this study is to evaluate the feasibility and effectiveness of an at-home program of VR-based vestibular and oculomotor rehabilitation on improving postural stability, ocular motility and activities of daily living for children with mild to severe ABI
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are ALYN patients undergoing physiotherapy for mild to severe ABI;
- •They experience symptoms of vestibular function such as vertigo, postural instability, or impaired ocular motility;
- •They are between the ages of 8 and 18;
- •The time since injury/event is between 10 days and 1 year after the injury/event;
- •They are able to maintain stable and dynamic positioning of the head;
- •They able to walk with or without assistive equipment, or use a wheelchairs with no need for head support, defined by a LSS (level of sitting scale) score of 3 or greater (scale range: 1-8);
- •Are able to understand basic instructions;
- •Have sufficient visual acuity and visual field to identify and track mid-size objects on a screen.
排除标准
- •Psychological, neurological or cognitive disorders which could impede participation, such as a history of epileptic seizures;
- •Untreated benign paroxysmal positional vertigo (BPPV);
- •Are in early post-operative stages (to avoid risk of bleeding or cerebrospinal fluid leak);
- •Hearing impairment.
结局指标
主要结局
Pediatric Vestibular Symptom Questionnaire (PVSQ)
时间窗: 6 months
Score ranging from 0 (never) to 33 (most of the time) with a 4-Likert scale
Vestibular Oculomotor Motor Screening (VOMS)
时间窗: 6 months
Symptoms scoring from 0 (none) to 10 (severe)
Convergence Insufficiency Symptom Survey (CISS)
时间窗: 6 months
Score ranging from 0 (never) to 56 (Always) with a 5-Likert scale
Dizziness Handicap Inventory for patients caregivers (DHI-PC)
时间窗: 6 months
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Dizziness Handicap Inventory (DHI)
时间窗: 6 months
Score ranging from 0 (none) to 100 (severe) with a 3-Likert scale
Pediatric Quality of Life Inventory (PEDSQL)
时间窗: 6 months
Score ranging from 0 (worst) to 100 (best) with a 5-Likert scale
Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)
时间窗: 6 months
Time score ranging from 0 (unable to complete) to 120 (completed successfully) in one of three 30-seconds trials and four conditions
Berg Balance Scale (Berg)
时间窗: 6 months
Score ranging from 0 (lowest level of function) to 56 (highest level of function) with a 5-Likert scale
次要结局
未报告次要终点