Comparison of Clinical and Game-based Rehabilitation for Balance Impairments and Gaze Dysfunction in Clients With Vestibular Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Standing Balance
研究概览
简要总结
Study Description and Purpose:
The vestibular sense organs of the inner ear consist of the semi-circular canals and otolith end organs. These organs contain specialized gravito-inertial sensors that sense angular and linear head acceleration. The input from these sensors is required to stabilize gaze position during head motion, and provide an absolute frame of reference with respect to gravity, thus providing a vertical spatial reference for body orientation and balance. Disease or damage of the vestibular sense organs causes a range of distressing symptoms and functional problems for people that could include loss of balance, gaze instability, disorientation and dizziness. A novel computer based rehabilitation system with therapeutic gaming application has been developed. This method allows different gaze and head movement exercises to be coupled to a wide range of inexpensive, commercial computer games. It can be used in standing and thus graded balance demands using a sponge pad can be incorporated into the program.
Study Objective:
- Test the therapeutic effectiveness of the TRP delivered in the home compared to usual care delivered in an out-patient physical therapy clinic on measures of balance (standing and walking) , gaze control, dizziness, and health related quality of life in individuals with peripheral vestibular disorders.
- Compare trajectory of change in electronic gaze performance measures obtained during each therapy session of each participant assigned to the home Telerehabilitation.
Hypothesis:
Investigators believe the Telerehabilitation platform to be a cost-effective delivery of rehabilitation. Additionally motivation to perform tedious home programs can be improved with engaging, fun and interactive computer gaming as part of the rehabilitation process. It is hypothesized the home game-based Telerehabilitation program will result in greater improvements in dynamic balance control, gaze control, and dizziness, in individuals with peripheral vestibular disorders as compared to a typical out-patient physical therapy regimen.
详细描述
Protocol
Design & Methodology:
This study will adopt a randomized clinical trial design. Recruitment and screening (including diagnostics) will be coordinated by co-applicant, Dr. Jordon Hochman, department of Otolaryngology, Karen Reimer, and Andrea Giacobbo,; Physical Therapists.
Inclusion criteria:
Consist of (a) age 18 to 65 , (b) diagnosed with unilateral peripheral vestibular hypo function based on a detailed neuro-otological and neuro-orthoptic analysis to include binocular electro-oculography with caloric testing, and (c) have a home computer running Windows or Mac OS.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Those with CNS disorders for example CVA, Multiple Sclerosis, epilepsy, migraines.
- •Recent fractures of the lower extremities or vertebra, advanced hip/knee OA ,
- •Cardiac disease .
结局指标
主要结局
Standing Balance
时间窗: Pre and post intervention of 12 weeks
This will be measured by performing a) Clinical Test of Sensory Integration of Balance and b) Five - Time Sit-to-Stand Test. Centre of Foot Pressure (COP) is recorded during test conditions and root mean square (RMS) and total Path Length ) in Medial-Lateral and Anterior-Posterior Directions is quantified.
Dizziness Handicap Inventory (DHI)
时间窗: Pre and post intervention of 12 weeks
It is a self-rating questionnaire based on 25 questions used to quantify a client's perception of his or her dizziness and its impact on their life.
Computerized Visual Tracking Performance
时间窗: Pre and post intervention of 12 weeks
A computer application has been developed which involves tracking a bright visual target moving horizontally left and right on a computer display in a sinusoidal fashion for several cycles, and at predetermined speeds. This procedure requires vestibular function and smooth pursuit to coordinate eye and head motions during the active head tracking task. The computer application records (80 Hz) coordinates of both reference and head cursors. Coefficient of determination (COD) will be computed based on total and average residual difference between trajectories of the reference and head cursor motions. A value approaching one equates to excellent gaze performance. This test will be performed in sitting, standing and while walking on a treadmill at 0.9 m/s
Spatial - temporal gait variables during treadmill walking with and without visual tracking task.
时间窗: Pre and post intervention of 12 weeks
It will be measured by asking the participants to walk on a treadmill for 1 minute which is instrumented with a pressure mat at a speed of 0.9 m/s. Average and coefficient of variation will be obtained for the following parameters: swing time, step time, step length and step width. Participants will repeat the: 1. Baseline walk not engaged in any visual tracking or head movement task 2. While performing the CDVA visual tracking task described above for 45 seconds
次要结局
未报告次要终点