Effects of Lokomat Training on Dynamic Postural Stability in Incomplete Spinal Cord Injury
2026年6月1日 更新者：I.R.C.C.S. Fondazione Santa Lucia
Evaluation of the Effects of Robotic Training on Dynamic Postural Stability, Symmetry, and Gait Smoothness in Subjects With Incomplete Spinal Cord Injury: a Randomized Controlled Trial
The study aims to evaluate the effects of robotic-assisted gait training (Lokomat) on dynamic postural stability in patients with incomplete spinal cord injury (SCI).
Participants will be randomized into two groups: one receiving robotic training and another receiving conventional postural stability exercises.
The primary evaluation will use the Mini-BESTest, supplemented by objective gait analysis using wearable inertial sensors (IMUs) to measure symmetry, fluidity, and stability.
A secondary objective is to compare these gait indices between SCI patients and healthy individuals.
研究概览
研究类型
介入性
注册 (估计的)
30
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。
学习地点
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RM
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Roma、RM、意大利、00179
- Santa Lucia Foundation, Scientific Institute for Research and Health Care
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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
是的
描述
Inclusion Criteria:
- Incomplete Spinal Cord Injury (ASIA scale C or D).
- Traumatic or non-traumatic, subacute or chronic.
- Walking Index for Spinal Cord Injury (WISCI) score > 5.
- Height ≤ 200 cm and Weight ≤ 135 kg.
Exclusion Criteria:
- Cognitive impairments preventing task comprehension.
- Grade 2 or higher pressure ulcers.
- Severe spasticity (Modified Ashworth Scale > 2).
- Orthopedic, vestibular, or other neurological comorbidities affecting gait.
- Severe heart failure or cardiovascular instability.
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention (Robotic)
12 sessions (3x/week, 40 min) of robotic gait training with adaptive speed, body weight support, and assistance levels.
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It is a robotic rehabilitation with Lokomat training.
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有源比较器：Control (Usual Care)
12 sessions (3x/week, 40 min) focused on sensorimotor recovery and non-robotic dynamic postural stability exercises.
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Conventional rehabilitation (Physiotherapy)
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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 |
|---|---|---|
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Mini-Balance Evaluation Systems Test (Mini-BESTest) Score
大体时间：Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Assessment of dynamic balance across 14 tasks (Score range: 0-28, with higher scores indicating better balance performance and lower fall risk).
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Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Berg Balance Scale (BBS)
大体时间：Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Static and dynamic balance assessment (Score range: 0-56, with higher scores indicating better balance performance and lower fall risk).
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Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Dynamic Gait Index (DGI)
大体时间：Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Ability to modify gait in response to task demands (Score range: 0-24, with higher scores indicating better balance performance and lower fall risk).
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Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Inertial Measurement Unit (IMU)-derived Gait Parameters
大体时间：Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Quantitative measures spatiotemporal gait parameters
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Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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IMU-derived Gait Parameters - Root Mean Square
大体时间：Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Quantitative measures of dynamic postural stability (Root Mean Square)
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Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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IMU-derived Gait Parameters -Improved Harmonic Ratio
大体时间：Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Quantitative measures of simmetry of gait (Improved Harmonic Ratio)
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Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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IMU-derived Gait Parameters -log dimensionless jerk
大体时间：Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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Quantitative measures of smoothness of gait (log dimensionless jerk)
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Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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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。
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
- Lorusso M, Tramontano M, Casciello M, Pece A, Smania N, Morone G, Tamburella F. Efficacy of Overground Robotic Gait Training on Balance in Stroke Survivors: A Systematic Review and Meta-Analysis. Brain Sci. 2022 May 31;12(6):713. doi: 10.3390/brainsci12060713.
- Di Tommaso F, Tamburella F, Lorusso M, Gastaldi L, Molinari M, Tagliamonte NL. Biomechanics of Exoskeleton-Assisted Treadmill Walking. IEEE Int Conf Rehabil Robot. 2023 Sep;2023:1-6. doi: 10.1109/ICORR58425.2023.10304685.
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 (实际的)
2026年5月15日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年5月15日
首先提交符合 QC 标准的
2026年6月1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6月1日
最后验证
2026年5月1日
更多信息
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.