Intermittent Hypoxia Paired with High Intensity Training in Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in gait speed
研究概览
简要总结
The central hypotheses are that HIT combined with AIH results in: 1) greater locomotor gains as compared to HIT alone; 2) improvements in gait quality and motor coordination during walking, and 3) changes in measures of community participation and integration.
详细描述
The central hypotheses are that HIT combined with AIH results in: 1) greater locomotor gains as compared to HIT alone; 2) improvements in gait quality and motor coordination during walking, and 3) changes in measures of community participation and integration. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of safety, feasibility, and preliminary efficacy of HIT+AIH. In this phase I-II trial, patients >6 months post-BI with mobility deficits will be allocated to 5 weeks (15 sessions) of HIT+AIH or HIT alone. Blinded assessments will be performed prior to and following training paradigms to address 3 specific aims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding of both participant with actual vs sham treatment and blinding of primary outcome assessments
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 6 months post brain injury
- •18-85 years old
- •ability to walk without physical assistance
- •Self selected walking speed of 0.01-1.0 m/s
排除标准
- •<18 years old
- •>85 years old
- •self selected walking speed of > 1.0 m/s
- •< 3 months from botulinum toxin injection above the knee brace
- •Currently receiving physical therapy
结局指标
主要结局
Change in gait speed
时间窗: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
Gait speed is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates. This measure will be performed by blinded assessors who do not participate in the training. Gait speed will be measured at self-selected speeds (SSS; instructions to "walk at normal comfortable pace") and fastest-possible speed (FS: "as fast as you safely can") using the Zeno Walkway (Protokinetics, Haverton, PA).
Change in Endurance
时间窗: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
Endurance is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates. This measure will be performed by blinded assessors who do not participate in the training. Gait endurance will be tested using the 6MWT (m) with instructions similar to SSS to minimize fall risk.
次要结局
- Metabolic capacity(Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks)
研究者
George Hornby
Professor of Physcial Medicine & Rehabilitation
Indiana University