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临床试验/NCT05759182
NCT05759182已完成不适用

The Effects of Exoskeletal Robot-Assisted Gait Training on Children With Cerebral Palsy: An Open-label, Pre-Post Comparison Pilot Study

COSMO ROBOTICS CO., Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Number of Participants with Improved Physical Activity

研究概览

简要总结

Cerebral Palsy (CP) is a complex neurodevelopmental disorder caused by early brain injury, leading to motor impairments such as muscle weakness, stiffness, and gait instability, which impact daily functioning. Gait training is crucial for improving mobility and independence in children with CP. Recently, robotic gait training (RAGT) devices, such as exoskeletons, have been explored as a rehabilitation tool. Although widely studied in adults, evidence of the effectiveness of RAGT in children with CP is limited. Preliminary studies have shown promising results in improving motor function and gait in children, yet more research is needed to validate its clinical efficacy comprehensively. This study aims to assess the impact of exoskeletal RAGT on daily activities, motor function, balance, and walking in adolescents with CP.

详细描述

Cerebral Palsy(CP) is a complex disorder caused by brain lesions that affect muscle tone, posture, movement, and gait. It is a neurodevelopmental, non-progressive disease caused by brain injury before the age of 3(1). The damaged brain results in persistent disability throughout childhood and beyond.

Cerebral Palsy is characterized by motor impairment that results in decreased muscle strength in certain muscles, causing muscle weakness, stiffness, contractures, and fatigue(2, 3). These features lead to decreased coordination between the muscles required to perform motor skills, which prevents the heel strike during gait(4), resulting in decreased motor control of body segments, decreased stride length, and increased gait instability, all of which contribute to poor gait quality(5, 6). Gait training, one of the main rehabilitation goals to improve the quality of life for children with Cerebral Palsy, aims to improve standing, walking, running, and hopping motor skills to help them live independently(7, 8).

Various types of robotic gait training devices have been developed to treat children with Cerebral Palsy. They are categorized into two types, exoskeleton and end-effector, depending on their principle of operation. The exoskeleton type moves joints such as hip, knee, and ankle joints to match the gait cycle. On the other hand, the end-effector type moves the foot by moving the footplate on which the body is supported(9).

Robot-assisted gait training (RAGT), an emerging area of rehabilitation, was initially developed for adults using driven gait orthoses (DGOs)(10, 11). Since the 21st century, several studies have reported that robot-assisted gait training improves walking performance in people with stroke or spinal cord injury. One systematic literature review reported that it is effective for the above conditions, but there is insufficient evidence for traumatic brain injury or Parkinson's disease(12, 13).

The robotic gait training device Lokomat (Hocoma, AG, Volketswil, Switzerland) has released a pediatric version of the gait training robot(14-16) to start gait training for children around four years of age. The usability of robotic gait training has been tested in the neurorehabilitation of pediatric diseases over the past several years. It was recently found that robotic gait training is a safe intervention method for children(17, 18). However, there is currently a significant lack of evidence regarding the clinical effectiveness of robotic gait training for various pediatric patient populations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • [Inclusion Criteria]
  • Patients with spastic cerebral palsy aged between 3 and 18 years.
  • Patients with gait disturbances due to lower limb weakness.

排除标准

  • Patients unable to understand and follow instructions.
  • Patients with severe lower limb spasticity scoring 3 or higher on the Modified Ashworth Scale.
  • Patients with severe gait disorders, scoring at or below Level 1 on the Functional Ambulation Category (FAC).
  • Patients with lower limb contractures, deformities, skin issues, neurological comorbidities other than cerebral palsy, or cardiovascular and other medical issues that may affect the ability to wear and walk with a robotic exoskeleton device.
  • Patients who refuse to participate in the study.

结局指标

主要结局

Number of Participants with Improved Physical Activity

时间窗: From enrollment to the end of treatment at 6 weeks

Estimates energy expenditure by measuring multi-directional physical movement acceleration using the wGT3X-BT accelerometer (ActiGraph LLC, Pensacola, FL, USA). The count values from the accelerometer are applied to a developed estimation formula to calculate energy expenditure.

Score on Gross Motor Function Measure (GMFM)

时间窗: From enrollment to the end of treatment at 6 weeks

A standardized outcome measure of overall motor function, widely used to assess changes in motor function over time in children with cerebral palsy. It evaluates five areas (A: lying and rolling; B: sitting; C: crawling and kneeling; D: standing; and E: walking, running, and jumping). The summed scores for each area are recorded as a percentage, demonstrating proven reliability and validity.

Classification Level on Gross Motor Function Classification System (GMFCS)

时间窗: From enrollment to the end of treatment at 6 weeks

The most widely used tool to assess the levels of movement that children with cerebral palsy can perform in daily life. It is a 5-level scale, where Level 1 indicates independent and functional movement, while Level 5 requires significant support, assistive devices, and caregiver assistance.

Time to Complete the Timed Up and Go Test (TUG)

时间窗: From enrollment to the end of treatment at 6 weeks

A reliable and practical tool for measuring basic functional mobility. The TUG test has demonstrated reliability as an assessment method for functional movement.

Distance Covered in the Six-Minute Walk Test (6MWT)

时间窗: From enrollment to the end of treatment at 6 weeks

An objective measure of exercise capacity, assessing the maximum distance an individual can walk on a flat surface in six minutes. This test is standardized in its procedures and measurements, providing a comprehensive assessment of physical capability.

Score on Pediatric Evaluation of Disability Inventory (PEDI)

时间窗: From enrollment to the end of treatment at 6 weeks

Developed by Haley et al. in 1992, PEDI assesses the functional status of infants and children aged 6 months to 7.5 years with disabilities. It is a standardized criterion-referenced tool with established reliability (ICC = 0.96-0.99) and validity, useful for clinical evaluation, monitoring progress, documenting functional improvements, and supporting clinical decision-making.

次要结局

  • Score on Korean Version of Cerebral Palsy Quality of Life Questionnaire (K-CP-Qol)(From enrollment to the end of treatment at 6 weeks)
  • Assessment on Skin Condition Changes(From enrollment to the end of treatment at 6 weeks)
  • Level of Spasticity Assessment(From enrollment to the end of treatment at 6 weeks)
  • Risk Analysis - Adverse Event Incidence Rate(From enrollment to the end of treatment at 6 weeks)
  • Rate of change in pain level(From enrollment to the end of treatment at 6 weeks)

研究者

发起方
COSMO ROBOTICS CO., Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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