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

June 11, 2025 updated by: COSMO ROBOTICS CO., Ltd

The Effects of Exoskeletal Robot-Assisted Gait Training on Children With Cerebral Palsy: An Open-label, Pre-Post Comparison Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Seongdong, Seoul, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

[Inclusion Criteria]

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

[Exclusion Criteria]

  1. Patients unable to understand and follow instructions.
  2. Patients with severe lower limb spasticity scoring 3 or higher on the Modified Ashworth Scale.
  3. Patients with severe gait disorders, scoring at or below Level 1 on the Functional Ambulation Category (FAC).
  4. 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.
  5. Patients who refuse to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bambini Teens Training
Ten participants will complete 30-minute sessions twice a week over six weeks, totalling 12 interventions.
Device: Powered Exoskeleton Gait Training
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.
Other Names:
  • Bambini Teens Gait Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on Korean Version of Cerebral Palsy Quality of Life Questionnaire (K-CP-Qol)
Time Frame: From enrollment to the end of treatment at 6 weeks
A tool to assess the quality of life specifically for individuals with cerebral palsy, adapted to the Korean population for culturally relevant evaluation.
From enrollment to the end of treatment at 6 weeks
Assessment on Skin Condition Changes
Time Frame: From enrollment to the end of treatment at 6 weeks
Evaluates overall skin condition, checking for bruising, swelling, erythema, and edema to monitor skin health and detect any abnormalities.
From enrollment to the end of treatment at 6 weeks
Level of Spasticity Assessment
Time Frame: From enrollment to the end of treatment at 6 weeks
Employs the Modified Ashworth Scale (MAS) to evaluate the level of muscle spasticity, a common condition in individuals with cerebral palsy.
From enrollment to the end of treatment at 6 weeks
Risk Analysis - Adverse Event Incidence Rate
Time Frame: From enrollment to the end of treatment at 6 weeks
Records instances of falls and malfunctions or errors of robotic walking devices, assessing the associated risks to ensure safety.
From enrollment to the end of treatment at 6 weeks
Rate of change in pain level
Time Frame: From enrollment to the end of treatment at 6 weeks
Uses the Wong-Baker Face Pain Rating Scale (FPRS) to measure and rate pain levels based on facial expressions, providing a reliable method for pain assessment.
From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

COSMO ROBOTICS CO., Ltd

Collaborators

Hanyang University

Investigators

  • Principal Investigator: Kyuhoon Lee, M.D., Department of Rehabilitation Medicine, Hanyang University Seoul Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Actual)

November 28, 2024

Study Completion (Actual)

November 28, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXO-CIP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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