Variable Intense Training for Ataxia and Locomotion (VITAL)
2026年5月27日 更新者：George Hornby、Indiana University
Feasibility and Potential Efficacy of High-intensity Gait Training in Individuals With Cerebellar Damage
The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease
研究概览
地位
尚未招聘
详细说明
The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Thomas G Hornby
- 电话号码：3123508291
- 邮箱：tghornby@iu.edu
研究联系人备份
- 姓名：Christopher Henderson
- 电话号码：3173292353
- 邮箱：henderce@iu.edu
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Ages 18-85
- >6 months following brain injury or diagnosis of cerebellar dysfunction
- A total score of > 4 on items 5-8 on the SARA for the ipsilateral limb
- Ability to ambulate 10 m at self-selected gait speeds (SSV) <1.2 m/s with no greater than minimal physical assistance permitted for postural stability only, but with below knee bracing and/or assistive device as needed
- Weight < 350 pounds
- Able to follow 1-step command
- Medical clearance to participate
Exclusion Criteria:
- Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
- Currently participating in other physical therapy
- >50 units of Botox within the past three months in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis
- Individuals deemed not stable between Pre-Baseline Testing and Baseline Testing
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：High-intensity training in variable contexts
High-intensity training focused on stepping tasks in variable contexts (tasks and environments) while targeting higher cardiovascular intensity (>75% maximum predicted heart rates) during up to 40 mins of 1-hr sessions.
A total of 20 sessions will be targeted.
|
High intensity stepping training: Training sessions will focus on maximizing stepping activities in variable contexts while targeting ≥70% HR reserve (or approximately 80% age-predicted maximum HR) calculated using the Karvonen formula.
Target HR will be decreased by 10 beats if the individual is on beta-blockers.
Intensity will also be monitored using the Borg RPE scale every 3-5 minutes with goals of ≥15 on a 6-20 scale.
The intensity of the walking training will be primarily modulated through the treadmill speed and incline as well as addition of weights to the torso or limbs for the purpose of error augmentation and not to dampen ataxia.
Sessions will focus on achieving up to 40 minutes of stepping training within each 60-minute session.
Potential tasks include walking in multiple directions, over inclines and obstacles, and/or with weighted vests and leg weights with limited handrail use as tolerated and decided by the therapist and participant.
其他名称：
|
|
有源比较器：Conventional balance training
Conventional balance activities will consist of sitting and standing balance exercises, with selected dynamic stability exercises performed during walking tasks.
Heart rates will be monitored with no targeted range.
All sessions will be 1-hr long with balance activities for up to 40 minutes per session.
A total of 20 sessions will be targeted.
|
Conventional training: Training sessions will focus on improving static and dynamic balance, while calculated using the Karvonen formula.
Target HR ranges will be decreased by 10 beats if the individual is on beta-blockers.
Intensity will also be monitored using heart rates and RPE every 3-5 minutes with goals of <14 on a 6-20 scale.
Sessions will focus on balance training for up to 40 minutes within a 60-minute session.
Individuals will perform ~10 minutes (~25% of sessions) on balance activities in the sitting position, ~20 minutes (50% of sessions) of standing positions and ~10 minutes (25% of sessions) of walking training.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
6-min walk test
大体时间：Changes from baseline to post-training following up to 20 sessions over approximately 8 weeks
|
Participants will walk for 6 minutes with instructions to "cover as much ground as they can".
|
Changes from baseline to post-training following up to 20 sessions over approximately 8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Thomas G Hornby、Indiana University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Keller JL, Bastian AJ. A home balance exercise program improves walking in people with cerebellar ataxia. Neurorehabil Neural Repair. 2014 Oct;28(8):770-8. doi: 10.1177/1545968314522350. Epub 2014 Feb 13.
- Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2028年6月15日
研究完成 (估计的)
2028年12月15日
研究注册日期
首次提交
2026年5月27日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- IU31611
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.