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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Cerebral Palsy, Gait Disorders, Neurologic, Gait Disorders in Children

Intervention / Treatment
-----------------
* Device: pediatric/adolescent exoskeleton walking system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with spastic cerebral palsy between the ages of 3 and 18 Patients with gait disturbance due to lower extremity weakness Weight, no more than 145lbs (65 kg) Skin must be healthy where it touches the exoskeleton Able to stand using a device such as a standing frame Determined to have enough bone health to walk full weight bearing without risk of fracture. Meeting of this condition is at the discretion of your personal physician Passive range of motion (PROM) at trunk and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid In general, good health and able to tolerate moderate levels of activity Blood pressure and heart rate within established guidelines for locomotive training: At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 100 or less Exercise; Systolic 180 or less, Diastolic 105 or less and Heart Rate 145 or less Exclusion Criteria: Inability to understand and follow instructions Severe lower extremity stiffness with a score of 3 or more as measured by the Modified Ashworth scale In case of functional gait index (FAC) level 1 or less with severe gait disorder Patients with lower extremity contractures, deformities, skin problems, neurological co-morbidities other than cerebral palsy, or cardiovascular and other medical problems that may affect walking while wearing a robotic walking device Patients who refused to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: ExoAtlet Bambini exoskeleton Safety and Efficacy 8 participants with cerebral palsy will participate in gait training using a pediatric/adolescent powered exoskeleton. Intervention: Device: Gait training using exoskeleton
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerebral Palsy gait training using a pediatric exoskeleton<br>ExoAtlet Bambini Outcome, Safety, and Efficacy 8 participants with cerebral palsy will participate in gait training using ExoAtlet Bambini powered exoskeleton. Intervention: Device: Gait training using ExoAtlet exoskeleton | Device: pediatric/adolescent exoskeleton walking system<br>* A pediatric/adolescent exoskeleton will be differentially applied according to each patient's gait level, 30 minutes a day, 3 times a week, 24 times in total for 8 weeks. When applying the intervention, the use of an appropriate stabilizing device (crutches, cane, harness, etc.) will be used according to the gait level of the study subject.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Gross Motor Functional Assessment (GMFM) | Assess changes, if any, in Gross Motor Functional Assessment from baseline to completion (with measurements at 4 weeks and 8 weeks). GMFM is a standardized outcome measure of total motor function and widely measures changes in total motor function over time in cerebral palsy in 5 domains (A. lying down and rolling, B. sitting, C. crawling and kneeling, D. standing, and E. walking, running and jumping), and demonstrating reliability and validity by recording the sum of each domain item as a percentage. | 8 weeks | 
| Changes in Pediatric Balance Scale (PBS) | Assess changes, if any, in the Pediatric Balance Scale, from baseline to completion (with measurements at 4 weeks and 8 weeks). PBS is a modified version of the Berg Balance Scales for assessing postural control balance, and proves reliable as a useful tool for assessing functional balance in cerebral palsy. | 8 weeks | 
| Changes in Modified Bardel Index (MBI) | Assess changes, if any, in the Modified Bardel Index, from baseline to completion (with measurements at 4 weeks and 8 weeks). MBI is a reliable and valid method to demonstrate and document improvements in basic daily living functions. | 8 weeks | 
| Changes in Timed Up and Go (TUG) | Measure changes, if any, in the Timed Up and Go test, from baseline to completion (with measurements at 4 weeks and 8 weeks). TUG test has proven its reliability as a reliable and practical test tool for measuring basic functional mobility. Improvements in TUG will be documented. | 8 weeks | 
| Changes in Range of Motion | Measure changes, if any, in lower extremity Range of Motion, from baseline to completion (with measurements at 4 weeks and 8 weeks). ROM will be assessed and documented at the ankle joints, knee joints, and hip joints, bilaterally. | 8 weeks | 
| Changes in Manual Muscle Testing | Measure changes, if any, in lower extremity Manual Muscle Testing, from baseline to completion (with measurements at 4 weeks and 8 weeks). | 8 weeks | 
| Changes in 1 minute walk test (1MWT) | Measure changes, if any, in the 1 minute walk test, from baseline to completion (with measurements at 4 weeks and 8 weeks). The 1MWT is a valid and reliable evaluation tool used for cerebral palsy to determine walking efficiency and improvements. | 8 weeks | 
| Changes in gait speed | Measure changes, if any, in the 10 meter walk test, from baseline to completion (with measurements at 4 weeks and 8 weeks). The 10MWT is a reliable and valid tool to asses to gait speed. | 8 weeks | 
| Changes in bio-mechanical joint angles and parameters during gait Analysis System (Human Track Gait Analysis Training System) | Using a Gait Analysis System (Human Track Gait Analysis Training System) that extracts 3D joint angles and parameters using a stereo vision sensor to determine changes and/or improvements to gait bio-mechanics | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Document and track any minor or major adverse events (falls and/or exoskeleton malfunctions). | 8 weeks | 
| Skin integrity assessment | Users' skin, in areas contacting the exoskeleton will be evaluated pre and post exoskeleton training session to identify any bruising, swelling, erythema, etc. | 8 weeks | 
| Pain assessment | Pain assessment will be evaluated using Wong-Baker face pain rating scale; FPRS, with 0 being no pain and 10 being the most pain. | 8 Weeks | 
| Stiffness Ratings Modified Ashworth Scores; MAS | The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity. It is characterized by exaggerated deep tendon reflexes that interfere with muscular activity, gait, movement, or speech | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Palsy, Exoskeleton, Gait, Walking