A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Protocol Adherence
研究概览
简要总结
This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. The investigators will collect additional clinical data in a subset of participants who agree to undergo additional assessments in the Motion Analysis Laboratory at the Spaulding Rehabilitation Hospital in Boston, MA during two in-person data collection sessions. The investigators will assess feasibility and acceptability of the Tele-Tai Chi intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, balance, and gait; and evaluate longitudinal changes in Tai Chi proficiency.
详细描述
The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a single-arm feasibility study for community-dwelling TC-naïve older adults. The investigators will assess feasibility and acceptability of the Tele-TC intervention and its specific components through both qualitative and quantitative feedback, as well as the systematic tracking of adherence data to inform future trials and potential clinical use of the Tele-TC system. The investigators will also explore changes in outcome measures including physical activity, self-efficacy, quality of life, and gait, and evaluate changes in TC proficiency.
Over the course of the 12-week program, participants will be assessed 4 times (baseline, two follow-up assessments at 4 and 8 weeks respectively, and a final assessment at 12 weeks).
Study volunteers will be instructed to train on their own at least three times a week and to participate in 1:1 live sessions with TC instructors two or more times during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 60 and 85 years old
- •TC naïve (i.e., never practiced TC)
- •Self-reported ability to walk continuously for 15 minutes without an assistive device
- •Working email address
- •Prior experience with and current access to a computer, smart phone or tablet device
排除标准
- •Chronic neuromuscular conditions (e.g. Parkinson's disease, multiple sclerosis, stroke)
- •Acute medical conditions requiring hospitalization within the past 6 months or that could interfere with the ability of prospective volunteers to safely participate in the study
- •Active cancer
- •Significant musculoskeletal conditions requiring chronic use of pain medication
- •Cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score < 18)
结局指标
主要结局
Protocol Adherence
时间窗: Post-intervention (approximately 12 weeks)
The percentage of Tai Chi home practice sessions completed by participants.
Retention
时间窗: Through study completion, approximately 12 weeks from the beginning of the study
The percentage of participants who complete the study.
System Usability Scale
时间窗: Post-intervention (approximately 12 weeks)
The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability.
次要结局
未报告次要终点
研究者
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital