A Tai Chi Based Exercise Program Provided Via Telerehabilitation Compared to During Home Visits in Persons Post-Stroke Who Have Returned Home Without Intensive Rehabilitation: A Randomized, Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- Change from baseline in mobility at 2 and 4 months
研究概览
简要总结
Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related to stroke. The platform used will be based on a technological infrastructure that was developed and tested in previous telerehabilitation studies. The study is a randomized control trial (RCT).The study population of interest will target individuals who have had a stroke who stayed in a hospital or chronic stroke population. Participants will be recruited during the hospitalization period at each of the three sites or in the community. The investigators expect to recruit 240 participants, 120 per group. The first evaluation will be conducted at recruitment to establish the baseline measures. The two other evaluations will be conducted 2 months (T2) and four months (T3) following recruitment.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have had a stroke with a Rankin score of 2 or 3;
- •was not referred to an Intensive Functional Rehabilitation Unit (IFRU) and returned home following discharge from hospital;
- •understands instructions to allow participation in evaluations and interventions;
- •has a balance problem as evidenced by a score between 46 and 54 on the Berg Balance Scale96;
- •has a caregiver that would be available during the telerehabilitation sessions to ensure safety during exercises;
- •live in an area serviced by high speed Internet.
排除标准
- •severe body hemineglect;
- •significant hemianopsia visual problems accompanied by hemineglect;
- •uncontrolled medical problems;
- •moderate to severe aphasia
结局指标
主要结局
Change from baseline in mobility at 2 and 4 months
时间窗: before the intervention, month 2 and month 4
Community balance and mobility Scale.
Change from baseline in Balance at 2 and 4 months
时间窗: before the intervention, month 2 and month 4
Community balance and mobility Scale.
次要结局
- Change from baseline walking speed at 2 and 4 months(before the intervention, month 2, month 4)
- Change from baseline aptitude for Balance at 2 and 4 months(before the intervention, month 2 and month 4)
- Change from Baseline Satisfaction with the care received at 2 and 4 months(before the intervention, month 2, month 4)
- Change from baseline Quality of life at 2 and 4 month(before the intervention, month 2, month 4)
- Change from baseline walking endurance at 2 and 4 months(before the intervention, month 2 and month 4)
- Change from baseline Psychological Attitudes related to mobility at 2 and 4 months(before the intervention, month 2, month 4)
- Change from baseline Psychological Attitudes related to balance at 2 and 4 months(before the intervention, month 2, month 4)
- Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months(before the intervention, month 2, month 4)
- Change from baseline Strength of lower limbs at 2 and 4 months(before the intervention, month 2 and month 4)
研究者
Michel Tousignant
Professor, PH.D.
Université de Sherbrooke