The Effectiveness of Perturbation Training With Balance Tutor, Compared to Balance and Strengthening Exercise, on Falls Rate Among Elderly at Risk of Falling
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- rate of falls and fallers
研究概览
简要总结
One third of adults over 65 and 50% of adults above 80 years old fall at list once a year. In some cases, falls result in fractures, hospitalization, functional limitations, depression, morbidity and mortality. Strong evidence support exercise training programs for fall prevention, while several studies examined the effect of perturbation training on risk of fall. The aim of this study is to evaluate the effectiveness of a perturbation training program with unexpected perturbation using balance tutor on falls and injuries among elderly at risk of falling, compared to balance and strengthening exercise.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one fall during the last 12 months; age 65-85; mini-mental state examination score 24 and above allowing cognitive ability to understand simple instructions ; Time Up and Go (TUG), assessing balance, walking ability and fall risk, scored 13 and above ; ability to read Hebrew or Arabic; and the ability to walk independently 10 meters.
排除标准
- •progressive neurological conditions (Parkinson, Multiple sclerosis, CVA); severe orthopedic conditions including lower limb or spine fractures and surgeries in the past 12 months prior to baseline; blindness; Arrhythmia; uncontrolled chronic disease (i.e., hypertension, diabetes, ischemic heart disease); diagnosed severe osteoporosis with a history of fracture during the past 3 years prior to baseline; active cancer during the past three years prior to baseline; lack of availability in the coming two months for completing the treatment protocol
研究组 & 干预措施
Perturbation training
Session1 - baseline assessment (detailed above) Session2 - 13 - each session will begin with reassessment and documentation of balance tutor parameters for each participant as were calibrated at the end of previous session.
After reassessment the training program will include:
- Warm up - walking without perturbation.
- Perturbation during standing position.
- Perturbation during walking.
- Perturbation during tandem position.
- Perturbation with vestibular stimulation.
- Rest according to patient needs The relative duration of each component, as well as intensity and frequency of perturbations, will be adjusted to each individual according to his ability, reassessment parameters and progression.
Session14 - full reassessment of all baseline examinations including: Mini-BESTest, ABC scale, PASE, and number of falls.
干预措施: Balance Tutor Biofeedback Rehabilitation System (Device)
Balance and strengthening exercise
Session1 - baseline assessment (detailed above).
Session2 - 13 - each session will include:
- Warm up (free walking or cycling).
- Static balance exercise - standing position. Exercise will be performed using different bases of support (narrow, tandem, and one leg stance), eyes open/closed, unstable surfaces, functional and cognitive dual task, and vestibular stimulation.
- Dynamic balance exercise - walking position. Exercise will be performed using different bases of support (narrow, tandem, and one leg stance), eyes open/closed, unstable surfaces, functional and cognitive dual task, and vestibular stimulation.
- Strengthening exercise - general strengthening, particularly for lower limb.
- Cool down. Level of difficulty and duration of each component will be adjusted to each individual according to his ability and progression.
Session14 - full reassessment of all baseline examinations including: Mini-BESTest, ABC scale, PASE, and number of falls.
干预措施: Balance and strengthening exercise (Other)
结局指标
主要结局
rate of falls and fallers
时间窗: falls and fallers rates during 12-months following end of treatment
hip fractures and hospitalizations rates due to falls
时间窗: hip fractures and hospitalizations rates due to falls during12-months following end of treatment
次要结局
- Mini-BESTest(end of treatment-last visit in physical therapy clinic)
- Activities-Specific Balance Confidence Scale (ABC scale)(12 months after end of treatment)
- Physical Activity Scale for the Elderly (PASE)(12 months after end of treatment)