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临床试验 NCT05218447 (DOOR SCI) 针对脊髓损伤目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury (DOOR SCI)
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临床试验NCT05218447 (DOOR SCI)是一项针对脊髓损伤的干预性研究试验，目前试验状态为招募中。试验始于2022年5月20日，计划招募144名患者。该研究由Baylor Research Institute主导，预计于2025年9月14日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年2月6日。
简要概括
The DOOR SCI project examines dosing effects of robotic gait training (RGT) and transcranial magnetic stimulation (TMS) initiated during inpatient rehabilitation and continued through early outpatient rehabilitation
详细描述
Emerging evidence indicates that robotic exoskeleton use results in positive outcomes for those with chronic SCI, yet limited evidence exists for the acute setting. The potential benefit of RGT initiated during inpatient rehabilitation when recovery is greatest is unknown yet appears promising due to established principles of neuroplasticity and the fact that RGT incorporates the critical components of gait training. As a result of the lack of evidence, no clinical practice guidelines exist that delineate which gait retraining approach or dose during early phases of recovery results in the best outcomes for people with motor incomplete SCI. The DOOR SCI project examines dosing effects on 5 occasions over 9 months: (1) inpatient rehabilitation admission and (2) discharge, (3) after completing 24 RGT sessions, (4) 1-month post RGT, and (5) 9-months post SCI). To test the overarching goal, investigators propose three specific aims:
Aim 1: Using a randomized controlled trial, prospectively examine whether the dosing frequency [24 sessions delivered as high, moderate, or low frequency, defined by number days/week (4, 3, or 2 days/week over 6, 8, 12 weeks)] of RGT therapy provided during the acute/subacute recovery phase after motor incomplete SCI impacts outcomes compared to usual care only.
Aim 2: Investigate the difference over 9 months of the neuroplastic effect of RGT dosing as measured by single pulse TMS.
Aim 3: Evaluate the safety, tolerability, and feasibility of delivering different dosing frequencies of RGT from inpatient to outpatient rehabilitation settings.
官方标题
Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury
疾病
脊髓损伤出版物
关于此临床试验发表的科学文章和研究论文：- Swank C, Trammell M, Bennett M, Ochoa C, Callender L, Sikka S, Driver S. The utilization of an overground robotic exoskeleton for gait training during inpatient rehabilitation-single-center retrospective findings. Int J Rehabil Res. 2020 Sep;43(3):206-213. doi: 10.1097/MRR.0000000000000409.
- Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Disabil Rehabil Assist Technol. 2020 May;15(4):409-417. doi: 10.1080/17483107.2019.1587014. Epub 2019 Mar 19.
- DiPasquale J, Trammell M, Clark K, Fowler H, Callender L, Bennett M, Swank C. Intensity of usual care physical therapy during inpatient rehabilitation for people with neurologic diagnoses. PM R. 2022 Jan;14(1):46-57. doi: 10.1002/pmrj.12577. Epub 2021 Apr 15.
- Swank C, Galvan C, DiPasquale J, Callender L, Sikka S, & Driver D. Lessons Learned with Robotic Exoskeleton Use During Rehabilitation - therapeutic and medical severity considerations. Technology & Disability. 2020; 32(2): 103-110.
- Suhalka A, da Silva Areas FZ, Meza F, Ochoa C, Driver S, Sikka S, Hamilton R, Goh HT, Callender L, Bennett M, Shih HT, Swank C. Dosing overground robotic gait training after spinal cord injury: a randomized clinical trial protocol. Trials. 2024 Oct 18;25(1):690. doi: 10.1186/s13063-024-08503-0.
其他研究标识符
- DOOR SCI
- BSWRI IRB 021-205
NCT编号
实际开始日期
2022-05-20
最近更新发布
2025-02-06
预计完成日期
2025-09-14
计划入组人数
144
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Exoskeleton
Wearable assistive technology
Transcranial magnetic stimulation
Robotic gait training
Wearable assistive technology
Transcranial magnetic stimulation
Robotic gait training
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Low Frequency Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks | Robotic Gait Training Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity. |
实验性Moderate Frequency Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks | Robotic Gait Training Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity. |
实验性High Frequency Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks | Robotic Gait Training Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity. |
阳性对照Control Group Subjects will receive usual care gait training without robotic gait training | Usual Care (UC) Gait Training Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will complete gait training with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline | The WISCI-II defines the physical limitation for gait secondary to impairment at the person level and indicates the ability of a person to walk after SCI. The WISC-II rank orders the ability a person to walk on a scale of 0-20 with 0 representing no ability to stand or participate in assisted walking and 20 representing an ability to walk 10 meters with no devices, no braces, and no physical assistance. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in 10-Meter Walk Test (10MWT) | The 10MWT assesses gait speed (m/s) over a short duration. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Spinal Cord Independence Measure (SCIM) | The SCIM assesses the ability of a person with spinal cord injury (SCI) to preform specified tasks independently, with assistance, or with assistive devices.
SCIM is composed of 19 items with total SCIM scores ranging from 0 (required assistance) to 100 (independence). A higher score means greater independence. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Numerical Pain Rating Scale (NPRS) | Pain is a significant problem in many individuals with SCI. A 0-10 Point Numerical Pain Rating Scale (NRS) is recommended as the outcome measure for pain intensity after SCI during acute and subacute phases. Pain severity can be categorized into 3 distinct groups as relates to pain interference: 1-3 (mild), 4-7 (moderate), 8-10 (severe). A higher score means greater pain severity. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) is used to measure fatigue in neurologic disorders and measures the effects of fatigue on function. It is measure on the following scale:
1. \- Strongly Disagree
2. \- Disagree
3. \- Slightly Disagree
4. \- Neutral
5. \- Slightly Agree
6. \- Agree
7. \- Strongly Agree A higher score means greater fatigue. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Penn Spasm Frequency Scale (PSFS) | The PSFS is a self-report measure to assess a patient's perception of spasticity frequency and severity following a SCI. With excellent internal consistency (ICC = 0.90), the current version was modified from the original to include both frequency and severity. A higher score means greater magnitude in spasms. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Patient Health Questionnaire - 9 (PHQ-9) | The PHQ-9 is a self-report measure to assess the presence of depressive symptoms. Each items is scored on the following scale:
0 - not at all
1. \- several days
2. \- more than half the days
3. \- nearly daily
Total scores are calculated by adding all the score and provides a possible depression severity score:
none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). A higher score means greater severity in depressive symptoms. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Life Satisfaction Questionnaire (LISAT) | The LISAT is a nine-item quality of life questionnaire suitable for SCI populations containing a single item assessing overall life satisfaction, along with eight additional domain-specific items. Items are answered on a 6-point likert scale that ranges from 1 (very dissatisfied), to 6 (very satisfied). The total Life Satisfaction score is computed as the mean of the item scores and the results are divided into dissatisfied (1-4) and satisfied (5-6). A higher score score means greater life satisfaction. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Physical Activity by GT9x Actigraph accelerometer | Active energy expenditure will be measured in counts per day using a GT9x Actigraph accelerometer. Patient will be instructed to wear the watch on an unaffected wrist for one week. Higher counts represent greater physical activity. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Neurophysiologic biomarkers by single pulse transcranial magnetic stimulation (TMS) | Motor evoked potential (MEP) amplitudes will be measured and indexed from lower extremity muscle by single pulse transcranial magnetic stimulation (TMS). | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
16 Years
适龄性别
全部
- All types of motor incomplete SCI (traumatic and non-traumatic)
- Acute/Subacute phase of recovery
- Medically stable as deemed by physician
- Undergoing medical care and rehabilitation at Baylor Scott & White Institute for Rehabilitation
- Both genders and all races and ethnicities
- Meet the Ekso robotic exoskeleton frame limitations
- Continence of or a program for bladder and bowel management
- Concurrent moderate to severe traumatic brain injury (TBI)
- Degenerative diagnoses
- Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment
- Pregnancy
Baylor Research Institute- United States Department of Defense
- Texas Woman's University
研究责任方
Chad Swank, 主要研究者, Research Investigator, Baylor Research Institute
研究中心联系人
联系人: Faith Meza, MPH, 469-531-1577, [email protected]
联系人: Christa Ochoa, MPH, [email protected]
1 位于 1 个国家/地区的研究中心
Texas
Baylor Scott & White Institute for Rehabilitation, Dallas, Texas, 75246, United States
Baylor Scott & White Institute for Rehabilitation, 联系人
招募中