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临床试验 NCT05926635 针对脑瘫目前进行中（不再招募）。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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Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy 60 儿科
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临床试验NCT05926635是一项针对脑瘫的观察研究试验，目前试验状态为进行中（不再招募）。试验始于2023年8月3日，计划招募60名患者。该研究由MarsiBionics主导，预计于2025年5月11日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年9月27日。
简要概括
Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP.
详细描述
A sample of children with CP will be divided into 2 groups, the experimental group will receive 32 sesions withe the ATLAS 2030 exoskeleton, whereas the control group will continue to receive their regular conventional therapy. Assessments will be performed at the beginning and the end of the intervention, as well as after 6, 9 and 12 months of the end of the intervention for follow-up.
官方标题
Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy
疾病
脑瘫其他研究标识符
- SERMAS
NCT编号
实际开始日期
2023-08-03
最近更新发布
2024-09-27
预计完成日期
2025-05-11
计划入组人数
60
研究类型
观察研究
试验状态
进行中（不再招募）
关键词
exoskeleton
cerebral palsy
gait
rehabilitation
cerebral palsy
gait
rehabilitation
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Exoskeleton group sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their of their routine rehabilitation | ATLAS 2030 sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their routine rehabilitation |
Control group The children included in the control group will continue receiving their usual conventional therapy | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Gross Motor Function Measure-88 (GMFM-88) | To measure changes in gross motor function in children with cerebral palsy using the Gross Motor Functional Measure-88.
The minimum value is 0 and the maximum value is 100 .When the GMFM score is lower, the skill level is lower. | At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Modified Ashworth Scale (MAS) | changes in spasticity measured by the Modified Ashworth Scale (MAS). The spasticity of each muscle group is measured with a scale scored from 0 to 4, where 0 means no spasticity and 4 means the joint is fixed and therefore, the highest level of spasticity | Through study completion, along 1 year |
Pediatric Quality of Life Inventory (PedsQLTM) | Changes in self perceived quality of life measured by the Pediatric Quality of Life Inventory (PedsQLTM). Every item is measured on a scale from 0 (higher quality of life) to 4 (lower quality of life) | At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up) |
Changes in Gait Deviation Index (GDI) | Changes in Gait Deviation Index (GDI) measured with a tridimensional motion analysis system | At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up) |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
3 Years
适龄性别
全部
- Medical authorization for standing, gait training and weight bearing.
- Informed consent signed by legal guardians.
- Confirmed diagnosis of cerebral palsy GMFCS levels III or IV.
- Proper family acceptance and commitment level.
- Receiving a minimum of 2 hours of therapy/activities promoting physical activity.
- Maximum user weight of 35 kg.
- Hip width (between greater trochanteres) less than or equal to 35 cm.
- Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
- Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
- Shoe size 27-33 (EU)
- More than 8 sessions of robotic therapy during a month in the previous year to the beginning of the study.
- Intensive rehabilitation during the study.
- Imposibility of the family to fulfill treatment calendar.
- Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
- More than 20º of hip and/or knee flessum at the time of using the exoskeleton.
- Necessity to walk with 10º of hip abduction.
- Necessity to walk with more than 9º of ankle dorsiflexion or plantar flexion or impossibility to use an orthosis to reach 90º in the ankle joint.
- Severe skin lesion on parts of the lower extremities that are in contact with the device.
- Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
- History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
- Severe rigid orthopedic deformities of the spine and/or lower limbs.
- Cognitive or conductual disorders that may lead to a lack of adherence to the attachment to the device.
- Conditions that provoke exercise intolerance.
- Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness or the inability to understand simple comands.
- Allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
MarsiBionics没有联系数据。
5 位于 1 个国家/地区的研究中心
Hospital Universitario Gregorio Marañón, Madrid, 28007, Spain
Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación, Madrid, 28009, Spain
Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia, Madrid, 28009, Spain
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Hospital Universitario La Paz, Madrid, 28046, Spain