Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Berg Balance Scale score change
研究概览
简要总结
Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Sensory augmentation is a method by which non-invasive vibration is used to enhance the sensory information available to users, which may make it easier to feel where they are and prevent losses of balance.
详细描述
The objective of this study is to design a novel multisensory augmentation approach to improve the control of standing balance in people with chronic stroke. With sensory augmentation, artificial feedback provides the nervous system with information about the dynamic state of the body, which can be used to prevent losses of balance. This clinical trial will investigate whether multisensory augmentation produces sustained balance improvements when applied as a training device. These potential improvements will be assessed by comparing the results of clinical and biomechanical assessments before and after a 10-week balance training program, in which half of the participants will be randomly assigned sensory augmentation.
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
Outcomes assessors will not be informed of which group participants are assigned to, and will not be present during an training sessions. As participants will be aware whether or not they will receive sensory augmentation (in the form of vibration), they can not be masked.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of at least 21 years;
- •Experience of a stroke at least 6 months prior to participation;
- •Berg Balance Scale score less than 52
- •Ability to stand independently for at least 1 minute without wearing an AFO or other brace that would preclude delivery of stimulation to the ankle or foot sole
- •Provision of informed consent
排除标准
- •Resting blood pressure higher than 220/110 mm Hg
- •History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- •Pre-existing neurological disorders or dementia
- •Severe visual impairment
- •History of DVT or pulmonary embolism within 6 months
- •Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
研究组 & 干预措施
Sensory Augmentation
Participants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below.
干预措施: Balance training with sensory augmentation (Behavioral)
Control
Participants will receive balance training, without any sensory augmentation.
干预措施: Balance training (Behavioral)
结局指标
主要结局
Berg Balance Scale score change
时间窗: Before and after a 10-week period of balance training
A standard clinical assessment to measure balance performance during various functional tasks
次要结局
- Limits of Stability score (paretic direction)(Before and after a 10-week period of balance training)
- Limits of Stability score (non-paretic direction)(Before and after a 10-week period of balance training)
- Mediolateral center of pressure displacement(Before and after a 10-week period of balance training)
- Mediolateral center of pressure velocity(Before and after a 10-week period of balance training)