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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05759182
• Other study ID #: EAB2023CP
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: ExoAtlet
• Contact: Kyuhoon Lee, Professor
• Phone: 010-3681-7734
• Email: dumitru1[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• pediatric/adolescent exoskeleton walking system
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.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Medical Center, Seoul Hospital	Songdong	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
ExoAtlet	Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (20)

Borggraefe I, Klaiber M, Schuler T, Warken B, Schroeder SA, Heinen F, Meyer-Heim A. Safety of robotic-assisted treadmill therapy in children and adolescents with gait impairment: a bi-centre survey. Dev Neurorehabil. 2010;13(2):114-9. doi: 10.3109/17518420903321767. — View Citation

Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700. — View Citation

Damiano DL. Activity, activity, activity: rethinking our physical therapy approach to cerebral palsy. Phys Ther. 2006 Nov;86(11):1534-40. doi: 10.2522/ptj.20050397. — View Citation

Garvey MA, Giannetti ML, Alter KE, Lum PS. Cerebral palsy: new approaches to therapy. Curr Neurol Neurosci Rep. 2007 Mar;7(2):147-55. doi: 10.1007/s11910-007-0010-x. — View Citation

Goldstein M, Harper DC. Management of cerebral palsy: equinus gait. Dev Med Child Neurol. 2001 Aug;43(8):563-9. doi: 10.1111/j.1469-8749.2001.tb00762.x. No abstract available. — View Citation

Hesse S, Schmidt H, Werner C, Bardeleben A. Upper and lower extremity robotic devices for rehabilitation and for studying motor control. Curr Opin Neurol. 2003 Dec;16(6):705-10. doi: 10.1097/01.wco.0000102630.16692.38. — View Citation

Houlihan CM. Walking function, pain, and fatigue in adults with cerebral palsy. Dev Med Child Neurol. 2009 May;51(5):338-9. doi: 10.1111/j.1469-8749.2008.03253.x. No abstract available. — View Citation

Husemann B, Muller F, Krewer C, Heller S, Koenig E. Effects of locomotion training with assistance of a robot-driven gait orthosis in hemiparetic patients after stroke: a randomized controlled pilot study. Stroke. 2007 Feb;38(2):349-54. doi: 10.1161/01.STR.0000254607.48765.cb. Epub 2007 Jan 4. — View Citation

Hwang EO, Oh DW, Kim SY. Community ambulation in patients with chronic post-stroke hemiparesis: Comparison of walking variables in five different community situations. Korean Acad Phys Ther Sci. 2009;16(1):31-9.

Kim SK, Park D, Yoo B, Shim D, Choi JO, Choi TY, Park ES. Overground Robot-Assisted Gait Training for Pediatric Cerebral Palsy. Sensors (Basel). 2021 Mar 16;21(6):2087. doi: 10.3390/s21062087. — View Citation

Mayr A, Kofler M, Quirbach E, Matzak H, Frohlich K, Saltuari L. Prospective, blinded, randomized crossover study of gait rehabilitation in stroke patients using the Lokomat gait orthosis. Neurorehabil Neural Repair. 2007 Jul-Aug;21(4):307-14. doi: 10.1177/1545968307300697. Epub 2007 May 2. — View Citation

Meyer-Heim A, Borggraefe I, Ammann-Reiffer C, Berweck S, Sennhauser FH, Colombo G, Knecht B, Heinen F. Feasibility of robotic-assisted locomotor training in children with central gait impairment. Dev Med Child Neurol. 2007 Dec;49(12):900-6. doi: 10.1111/j.1469-8749.2007.00900.x. — View Citation

Morone G, Paolucci S, Cherubini A, De Angelis D, Venturiero V, Coiro P, Iosa M. Robot-assisted gait training for stroke patients: current state of the art and perspectives of robotics. Neuropsychiatr Dis Treat. 2017 May 15;13:1303-1311. doi: 10.2147/NDT.S114102. eCollection 2017. — View Citation

Opheim A, Jahnsen R, Olsson E, Stanghelle JK. Walking function, pain, and fatigue in adults with cerebral palsy: a 7-year follow-up study. Dev Med Child Neurol. 2009 May;51(5):381-8. doi: 10.1111/j.1469-8749.2008.03250.x. Epub 2008 Feb 3. — View Citation

Pirpiris M, Wilkinson AJ, Rodda J, Nguyen TC, Baker RJ, Nattrass GR, Graham HK. Walking speed in children and young adults with neuromuscular disease: comparison between two assessment methods. J Pediatr Orthop. 2003 May-Jun;23(3):302-7. — View Citation

Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480. — View Citation

Sutherland DH, Davids JR. Common gait abnormalities of the knee in cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):139-47. — View Citation

Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48(4):387-416. doi: 10.1682/jrrd.2010.04.0055. — View Citation

Wirz M, Zemon DH, Rupp R, Scheel A, Colombo G, Dietz V, Hornby TG. Effectiveness of automated locomotor training in patients with chronic incomplete spinal cord injury: a multicenter trial. Arch Phys Med Rehabil. 2005 Apr;86(4):672-80. doi: 10.1016/j.apmr.2004.08.004. — View Citation

Yoo M, Ahn JH, Park ES. The Effects of Over-Ground Robot-Assisted Gait Training for Children with Ataxic Cerebral Palsy: A Case Report. Sensors (Basel). 2021 Nov 26;21(23):7875. doi: 10.3390/s21237875. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of adverse events	Document and track any minor or major adverse events (falls and/or exoskeleton malfunctions).	8 weeks
Secondary	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
Secondary	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
Secondary	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