A Study on the Effects of Exoskeleton Robot Walking Training on Adolescents With Cerebral Palsy: A Preliminary Study

Cerebral Palsy Clinical Trial

Official title: A Study on the Effects of Exoskeleton Robot Walking Training on Adolescents With Cerebral Palsy: A Preliminary Study

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study was to investigate the effects of exoskeleton robot gait training on activities of daily living, gross motor function evaluation, balance and walking ability in adolescents with cerebral palsy.

Clinical Trial Description

Cerebral palsy (CP) is a group of complex disorders caused by a brain lesion(s) at birth, that affects a person's movement, muscle tension, posture, and balance. CP is a neurodevelopmental disease, that is non-progressive and caused by brain damage before the age of 15. While CP is a non-progressive disease, the movement, coordination and balance disorders typically remain and the damaged brain continues to be disabled throughout life1.

Cerebral palsy is muscle weakness due to a decrease in the strength of certain muscles, stiffness, build, and characterized by motor impairments that cause fatigue2,3. These characteristics affect motor performance and decrease coordination between the muscles necessary for walking. It interferes with the heel contacting the floor4 in gait, resulting in a decrease in the motor ability of the body segments, a decrease in stride length, and it is one of the factors that decreases the quality of gait due to the increase in gait instability5,6. Gait training, walking, jump, etc., are some of the main rehabilitation goals to improve the quality of life for children with cerebral palsy. The purpose of this training is to help people live an independent life by improving balance and walking motor skills7,8.

Various types of robotic gait training devices have been developed and implemented for gait treatment with children with cerebral palsy. These devices are divided into two types of operation: exoskeleton and end-effector. The exoskeleton type operates to move a user's joints such as the hip, knee, and ankle, according to the gait cycle. The later, end-factor devices are designed to move the user's the legs and/or feet through a desired motion, while the user rests in position on the footrest and the body is supported9.

Robot-assisted gait training (RAGT), which is being taken as one area of rehabilitation, was originally developed for adults using driven gait orthosis (DGO)10,11. Since the 21st century, several studies have reported that robot walking training improves the walking ability of stroke or spinal cord injury patients. This, in a systematic review study, has proven its effectiveness against the above diseases but, evidence is not yet sufficient for traumatic brain injury or Parkinson's disease12,13.

Lokomat (Hocoma, AG, Volketswil, Switzerland), a robotic walking device, has released a pediatric version of the walking robot to start gait training for children aged about 4 years to about 14-16 years, and has been used for neurorehabilitation of pediatric diseases for the past several years. As a result of testing whether gait training was used or not, it was recently revealed that robot gait training can be implemented as a safe intervention method for children17,18. However, there is currently very little evidence of the clinical effect of robot gait training targeting various pediatric diseases.

Robot gait training (Angel-legs, ANGEL ROBOTICS Co., Ltd., Seoul, Korea) targeting 3 children with cerebral palsy (9, 13, 16 years old) was recently conducted at a University Hospital. It was reported that gait speed and gait endurance were improved compared to the previous evaluation and with less energy19. In addition, it was reported that two children with ataxic cerebral palsy (11 and 12 years old) were trained with conventional intensive rehabilitation treatment and robot gait training in parallel, and the gross motor function evaluation, functional balance, and walking ability were all improved20 .

There is still insufficient evidence for robot gait training for various pediatric diseases, and no study has been conducted to prove its effectiveness through various evaluations. Therefore, the purpose of this study was to investigate the effects of exoskeleton robot gait training on activities of daily living, gross motor function evaluation, balance and walking ability in adolescents with cerebral palsy. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait Disorders in Children
• Gait Disorders, Neurologic
• Nervous System Diseases
• Paralysis

• NCT number: NCT05759182
• Study type: Interventional
• Source: ExoAtlet
• Contact: Kyuhoon Lee, Professor
• Phone: 010-3681-7734
• Email: dumitru1@hanyang.ac.kr
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Completion date: December 2023