Experimental Perturbation-based-training Study in Patients After Stroke and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Perturbation strength
研究概览
简要总结
The study will investigate safety, usability, feasibility and preliminary efficacy of perturbation-based training in participants post-stroke and older adults with mild balance deficits. Both group will receive three weks of training. The primary outcome measure will be derived from laboratory-induced falls.
详细描述
Two convenience samples will be recruited to serve as self-controls, 20 post-stroke adults and 30 community-dwelling older adults. Participants post stroke will be recruited after discharge from their regular rehabilitation. Each subject will undergo individually customised perturbation-based training sessions with safety harnesses. The participants will be assessed at four time points: at baseline, after 3 weeks (at the beginning of training), at the end of 3-week training, and at 3-week follow-up. Safety, usability and efficacy of training will be evaluated using slip-, trip- and platform-movement-based perturbations induced by a Stewart platform and dual-belt treadmill, whereby the perturbation strength that can be reliably counteracted will be recorded, and using standardised clinical outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for both arms:
- •ability for independent community walking without aids;
- •sufficient cognitive, visual, and communication abilities for study participation.
排除标准
- •for both arms:
- •musculoskeletal impairments;
- •cardiovascular health-related problems;
- •other health conditions that could interfere with the training.
- •Additional Inclusion Criteria for post-stroke patients:
- •discharge from their regular rehabilitation;
- •at least 6 months after first unilateral cerebral stroke;
- •18 to 70 years of age;
- •absence of additional neurologic conditions.
- •Additional Inclusion Criteria for older adults:
- •age 65 to 75 years;
- •no known health-related problems significantly affecting balance and walking.
研究组 & 干预措施
Post-stroke patients
Each participant will undergo perturbation-based training and assessment according to an ABA (no intervention/intervention/no intervention) design with assessment at the beginning and end of each phase (four time-points).
干预措施: PBT (Device)
Elderly adults
Each participant will undergo perturbation-based training and assessment according to an ABA (no intervention/intervention/no intervention) design with assessment at the beginning and end of each phase (four time-points).
干预措施: PBT (Device)
结局指标
主要结局
Perturbation strength
时间窗: Difference between the two assessments - one day before the first and one day after the last training session
Perturbation strength that can be reliably counteracted - difference score (minimum 0N, no upper limit, stronger perturbation means better outcome, larger difference means better outcome)
次要结局
- ABC Scale(Difference between the two assessments - one day before the first and one day after the last training session)
- mini-BESTest(Difference between the two assessments - one day before the first and one day after the last training session)