The Effects of Exoskeletal Robot-Assisted Gait Training on Children With Cerebral Palsy: An Open-label, Pre-Post Comparison Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- COSMO ROBOTICS CO., Ltd
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Participants with Improved Physical Activity
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed Description
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. A recent study conducted at a university hospital reported improvements in gross motor function, gait speed, and endurance with reduced energy expenditure following robotic gait training (Angel-legs, ANGEL ROBOTICS Co., Ltd., Seoul, Korea) for three children with cerebral palsy (ages 9, 13, and 16). Additionally, for two children with ataxic cerebral palsy (ages 11 and 12), combining conventional intensive rehabilitation therapy with robotic gait training led to reported improvements in gross motor function, functional balance, and walking ability(20). However, there is still a lack of evidence on robotic gait training for various pediatric diseases, and no studies have been conducted to demonstrate its effectiveness through various evaluations. Therefore, we aimed to investigate the effects of exoskeleton robotic gait training on activities of daily living, gross motor function assessment, balance, and walking ability in adolescents with Cerebral Palsy.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants with Improved Physical Activity
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)