Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Compensatory Step Execution Time
研究概览
简要总结
aim: To examine the effect of a perturbation-based balance training on balance reaction characteristics in post stroke individuals.
详细描述
60 stroke subjects from the neurology rehabilitation unit at Loewenstein hospital will be randomly allocated to one of two groups: 1) perturbations based balance training 2) weight shifting and gait training without external perturbations (control).
Group 1 - Perturbations based balance training Subjects will complete a perturbation based balance training while standing and walking on the BalanceTutor (MediTouch). Perturbation level will be individually adjusted and progressed according to subject's abilities. Progression occurs by increasing perturbation level (increase distance, velocity and acceleration). At each practiced level subjects will be exposed to random right/left/forward/backward unannounced platform translations while standing and to right/left perturbations (in defined events in gait cycle) while walking. In order to examine adaptation to repeated perturbations, kinematic data will be collected in the first session.
Group 2 - Weight shifting and gait training Subjects will complete a balance training program that includes voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. Weight shifting toward a target will be adjusted and progressed according to subject's abilities. Progression in difficulty level will occur by increasing the distance to target without changing the base of support. At each practiced level weight shifting will be conducted to right/left/forward/backward directions. In the gait part of the session, subjects will be asked to walk at their preferred treadmill walking speed.
Subjects in both groups will complete 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes and will include practice in standing and walking. Subject's activities will be documented in each session in both groups. Furthermore, in each session subjects will be asked to rate their perceived level of challenge on a 0-10 scale.
Pre- and post-intervention measurements will be conducted. A follow-up measurement will be conducted 3-6 weeks post intervention.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For measurements taken while standing, post stroke subjects will meet the criteria of being able to stand independently or with supervision for at least 2 minutes.
- •For measurements taken while walking, post stroke subjects will meet the criteria of being able to walk for at least 10 meter with supervision/independently without walking aids.
- •3 weeks-6 months post stroke (hemorrhage/infarct)
- •First stroke
- •Age 25-75 years
- •Able to understand research instructions
- •Stable clinical/metabolic state
排除标准
- •- A history of neurological diseases amongst peripheral neuropathy
- •Significant skeletal system diseases, such as severe osteoporosis
- •Uncontrolled atrial fibrillation
- •Unstable ischemic heart disease
- •Significant visual deficiency
- •Dizziness
- •Pregnancy
- •Body weight above 135 kg
研究组 & 干预措施
Perturbation-based balance training
perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).
10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.
干预措施: Stroke Subjects Perturbation-Based Balance Training (Device)
Weight shifting and gait training
Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.
10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.
干预措施: Stroke Subjects Weight Shifting and Gait training (Device)
结局指标
主要结局
Change in Compensatory Step Execution Time
时间窗: 1-5 days before the first session of intervention and 1-5 days after the last session of intervention.
Will be calculated as the time from platform perturbation to foot contact using a 3D motion analysis system. Step execution time in response to surface translations toward the non-paretic side.
Change in Compensatory Step Velocity
时间窗: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
will be calculated from step length and step swing time data, using a 3D motion analysis system. Step velocity in response to surface translations toward the non-paretic side.
次要结局
- Change in Berg Balance Scale Score(1-3 days before the first session of intervention and 1-3 days after the last session of intervention.)
- Change in Fall Threshold(1-3 days before the first session of intervention and 1-3 days after the last session of intervention.)
- Change in Activities-specific Balance Confidence (ABC) Scale(1-3 days before the first session of intervention and 1-3 days after the last session of intervention.)
研究者
Nachum Soroker, MD
head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel
Loewenstein Hospital