Baylor Scott & White Research Institute, Dallas, TX, USA.
Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.
Trials. 2024 Oct 18;25(1):690. doi: 10.1186/s13063-024-08503-0.
Robotic exoskeletons have changed rehabilitation care available to people after spinal cord injury (SCI). Yet, the current evidence base is insufficient to identify the optimal dose and neurophysiological mechanism of robotic exoskeleton gait training (RGT) as an effective rehabilitation approach. This study will (1) examine whether the frequency of RGT after motor incomplete SCI impacts function and health outcomes, (2) analyze the neuroplastic effects of RGT dose, and (3) evaluate the safety, tolerability, and feasibility of delivering RGT.
We will enroll 144 participants with motor incomplete SCI admitted to inpatient rehabilitation within 6 months of SCI. Participants will be randomized based on injury severity and level into one of 3 RGT frequency groups (high, moderate, low) or none/usual care only. Participants will complete 24 RGT sessions and be assessed at admission and discharge to inpatient rehabilitation, post-RGT intervention, 1-month post-RGT, and 9-month post-SCI. Outcomes include Walking Index for Spinal Cord Injury-II, health outcomes (gait speed, Spinal Cord Independence Measure, pain, fatigue, spasticity, general health, quality of life, physical activity), and motor evoked potential amplitudes obtained using transcranial magnetic stimulation.
Successful completion of this study will provide an evidence-based intervention, specifically tailored to meet the unique needs of people with SCI, which supports walking recovery; maximizing health, function, and ultimately participation. The intervention will further support widespread clinical implementation of exoskeleton use during acute rehabilitation.
ClinicalTrials.gov NCT05218447. Registered on June 23, 2022.
机器人外骨骼改变了脊髓损伤（SCI）后人们可获得的康复护理。然而，目前的证据基础还不足以确定机器人外骨骼步态训练（RGT）作为一种有效的康复方法的最佳剂量和神经生理机制。本研究将：（1）研究运动不完全性 SCI 后 RGT 的频率是否会影响功能和健康结果；（2）分析 RGT 剂量的神经可塑性效应；（3）评估 RGT 的安全性、耐受性和可行性。
我们将招募 144 名在 SCI 后 6 个月内入住住院康复的运动不完全性 SCI 患者。参与者将根据损伤严重程度和水平随机分为 3 个 RGT 频率组（高、中、低）或无/常规护理组。参与者将完成 24 次 RGT 疗程，并在住院康复期间、RGT 干预后、RGT 后 1 个月和 SCI 后 9 个月进行评估。结果包括脊髓损伤步行指数（Ⅱ）、健康结果（步态速度、脊髓独立性测量、疼痛、疲劳、痉挛、一般健康、生活质量、体力活动）和经颅磁刺激获得的运动诱发电位幅度。
成功完成本研究将提供一种循证干预措施，专门针对 SCI 患者的独特需求进行定制，以支持步行恢复；最大限度地提高健康、功能，最终提高参与度。该干预措施将进一步支持外骨骼在急性康复期间的广泛临床应用。
ClinicalTrials.gov NCT05218447。于 2022 年 6 月 23 日注册。
