The Effects of Exoskeletal Robot-Assisted Gait Training on Children With Cerebral Palsy: A Pilot Study

NCT05759182 | Completed

• 1 other identifier: EXO-CIP-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Gait Disorders; Gait Disorders in Children; Gait Disorders, Neurologic; Spastic Cerebral Palsy; Dyskinetic Cerebral Palsy; Diplegia

Keywords

Cerebral Palsy; Exoskeleton; Gait; Walking

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Improved Physical Activity

  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.

  From enrollment to the end of treatment at 6 weeks

• Score on Gross Motor Function Measure (GMFM)

  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.

  From enrollment to the end of treatment at 6 weeks

• Classification Level on Gross Motor Function Classification System (GMFCS)

  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.

  From enrollment to the end of treatment at 6 weeks

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

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

  From enrollment to the end of treatment at 6 weeks

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

  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.

  From enrollment to the end of treatment at 6 weeks

• Score on Pediatric Evaluation of Disability Inventory (PEDI)

  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.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

Bambini Teens Training

EXPERIMENTAL

Ten participants will complete 30-minute sessions twice a week over six weeks, totalling 12 interventions.

Device: Powered Exoskeleton Gait Training

Interventions

Powered Exoskeleton Gait Training DEVICE

A trained medical professional will adjust the exoskeleton to fit each participant and tailor the program(sit to stand, stand to sit, standing balance and weight shift, walk in place, walk forward) according to their physical condition and specific needs. Based on each participant's walking ability, appropriate safety devices (such as crutches, canes, or a harness) will be used during the intervention.

Also known as: Bambini Teens Gait Training

Bambini Teens Training

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• COSMO ROBOTICS CO., Ltd: lead
• Hanyang University: collaborator

Study Sites (1)

Hanyang University Seoul Hospital

Seongdong, Seoul, 04763, South Korea

Location

Related Publications (20)

• 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.

  PMID: 17370477 BACKGROUND

• 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.

  PMID: 19379288 BACKGROUND

• 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.

  PMID: 19207296 BACKGROUND

• 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.

  PMID: 11508924 BACKGROUND

• 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.

  PMID: 12724591 BACKGROUND

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

  PMID: 8458127 BACKGROUND

• 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.

  PMID: 17094192 BACKGROUND

• 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.

  PMID: 17324366 BACKGROUND

• 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.

  PMID: 28553117 BACKGROUND

• 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.

  PMID: 11321005 BACKGROUND

• 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.

  PMID: 14624080 BACKGROUND

• 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.

  PMID: 21674390 BACKGROUND

• 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.

  PMID: 17476001 BACKGROUND

• 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.

  PMID: 17204680 BACKGROUND

• 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.

  PMID: 15827916 BACKGROUND

• 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.

  PMID: 18039236 BACKGROUND

• 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.

  PMID: 20222772 BACKGROUND

• 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.

  PMID: 33809758 BACKGROUND

• 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.

  PMID: 34883877 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Mobility Limitation; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Kyuhoon Lee, M.D.

  Department of Rehabilitation Medicine, Hanyang University Seoul Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Single-Arm, Open-label, Pre-Post Comparison Study Design

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 8, 2023
• Study Start: September 2, 2024
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)