Vestibular Infant Screening - Rehabilitation (VIS-REHAB): Protocol for a Randomised Controlled Trial on Vestibular Rehabilitation Therapy (VRT) in Vestibular-impaired Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Static postural stability and sensory integration as assessed by the Modified Clinical Test of Sensory Integration on Balance (mCTSIB)
研究概览
简要总结
The goal of this clinical trial is to investigate the short-term effect of a structured, combined postural control and gaze stabilisation protocol (VIS-REHAB protocol) in a group of vestibular-impaired children of different age categories (3-17 years). The main questions it aims to answer are:
- What is the short-term effect of the VIS-REHAB protocol?
- What are the most important factors that may influence the effect of and outcome after application of the VIS-REHAB protocol?
The participant will undergo both an active rehabilitation program (VIS-REHAB protocol) and a period during which physical therapy is discontinued (CTRL protocol).:
- VIS-REHAB protocol: Postural control (static and dynamic postural stability exercises), gaze stability exercises (oculomotor function and VOR-exercises) & general gross motor training with focus on gaze stability and postural control.
Researchers will compare the VIS-REHAB protocol with receiving no therapy (CTRL protocol) to evaluate potential enhancements in postural stability, gaze stability, motor performance and quality of life.
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)
盲法说明
Participants cannot be blinded to their assigned groups, as they will be aware of the protocol received at any given time. The assessment of primary and secondary outcome measures will be conducted by a separate outcome assessor who will be blinded to patient allocation. Data analysis procedures will not involve blinding since they will be performed by the same individual responsible for conducting the rehabilitation sessions.
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with identified vestibular dysfunction
- •With or without concomitant hearing loss and/or cochlear implant (CI)
排除标准
- •Children incapable to understand simple instructions (due to severe cognitive disorders, impaired language comprehension, etc.)
- •Severe disorders of other primary sensory input systems for balance function
- •Severe neuromotor disorders (incapable of independent standing and walking)
- •Severe muscle tone disorders (e.g. cerebral palsy)
- •Severe orthopaedic dysfunctions
- •Patients with vision problems that cannot be corrected for
- •Children with planned CI-surgery within 5 months before or during the study period
研究组 & 干预措施
VIS-REHAB Protocol
The VIS-REHAB protocol entails 30-minute sessions conducted twice a week over a span of 9 weeks. These sessions are structured with 20 minutes dedicated to enhancing postural stability and 10 minutes focused on improving gaze stability. In greater detail, a minimum of 5 minutes time is reserved for counselling and providing background information on the exercises, focused on the vestibular issue. Apart from the counselling part, each session consist of 3 different exercise categories ((static postural stability, dynamic postural stability, general gross motor training (focus on PS), oculomotor function, gaze stability, or general gross motor training (focus on GS)), each carried out for 5 to 10 minutes.
干预措施: VIS-REHAB protocol (Behavioral)
CTRL Protocol
In the control (CTRL) protocol, all forms of physical therapy in the context of motor development are ceased. Occupational therapy, speech-language therapy and physical therapy for other purposes are not covered by this commitment. Additionally, the child and parents are asked to not do any home exercises on their own. However, sports activities and other recreational hobbies will not be asked to be temporary halted, since they will be continued in the active rehabilitation programme as well.
结局指标
主要结局
Static postural stability and sensory integration as assessed by the Modified Clinical Test of Sensory Integration on Balance (mCTSIB)
时间窗: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.
The child stands barefoot with feet together as still as possible for 30 seconds. There are eight test conditions: eyes open or closed, with or without foam, and eyes open or closed while on a foam, nodding the head in yaw or pitch at 0.33 Hz. The test will be conducted on a force platform, a Wii Balance Board (Nintendo Co., Ltd.), using the Colorado University BrainBLoX software. The total test time (s), anteroposterior and mediolateral sway (mm), centre of pressure path length (cm), sway velocity (m/s), and 95% confidence ellipse area (cm2 ) are measured by a custom-made code in MATLAB (The MathWorks, Inc. Natick, Massachusetts, United States).
Gaze stability as assessed by the Dynamic Visual Acuity (DVA) test
时间窗: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.
The setup of the test is similar to that of the Static Visual Acuity (SVA) test, the only difference being that the patient's head will be passively moved by the examiner in the horizontal plane at a 2Hz-frequency over an amplitude of 15° from centre. The difference between the SVA and the DVA score will be included as output measure.
次要结局
- Dynamic postural stability during walking as assessed by the Paediatric Modified Dynamic Gait Index (DGI)(At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period))
- Functional mobility and dynamic postural control during walking as assessed by the Timed Up and Go Test (TUG)(At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period))
- Quality of life as assessed by the Paediatric Quality of Life Inventory (PedsQL) 4.0(At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period))
- Superior and inferior vestibular nerve and the functioning of the six semicircular canals, using the vestibulo-ocular reflex (VOR) assessed by the video Head Impulse Test (vHIT)(At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period))
- Dynamic postural stability as assessed by the Paediatric Functional Reach Test(Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.)
- Fine and gross motor skill assessment assessed by the Bruininks-Oseretsky Test of Motor Proficiency 2 (BOT-2)(At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period))
- Static postural stability as assessed by the Single Leg Standing Test (SLS)(Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.)
- Functional evaluation of the VOR by the Functional Head Impulse Test (fHIT)(Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.)