AzTrials
AzTrials

Cerebral PalsyNCT05759182

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

A study testing Powered Exoskeleton Gait Training in people with Cerebral Palsy and Gait Disorders, run by COSMO ROBOTICS CO., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 3 to 18 years
What is being tested?
Powered Exoskeleton Gait Training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
2 Sep 2024to 28 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

[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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hanyang University Seoul Hospital

    Seongdong, Seoul, 04763

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Powered Exoskeleton Gait Training
Keywords
Cerebral Palsy, Exoskeleton, Gait, Walking
Medical subject headings
Cerebral Palsy, Mobility Limitation, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Powered Exoskeleton Gait TrainingDevice

    Also called Bambini Teens 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.

Study groups in NCT05759182
Study groupRoleWhat they receive
Bambini Teens TrainingExperimentalTen participants will complete 30-minute sessions twice a week over six weeks, totalling 12 interventions.
Receives: Device: Powered Exoskeleton Gait Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

  2. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

  3. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

  4. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

  5. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

  6. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

Secondary outcomes (5)

  1. Score on Korean Version of Cerebral Palsy Quality of Life Questionnaire (K-CP-Qol)

    A tool to assess the quality of life specifically for individuals with cerebral palsy, adapted to the Korean population for culturally relevant evaluation.

    Measured: From enrollment to the end of treatment at 6 weeks

  2. Assessment on Skin Condition Changes

    Evaluates overall skin condition, checking for bruising, swelling, erythema, and edema to monitor skin health and detect any abnormalities.

    Measured: From enrollment to the end of treatment at 6 weeks

  3. Level of Spasticity Assessment

    Employs the Modified Ashworth Scale (MAS) to evaluate the level of muscle spasticity, a common condition in individuals with cerebral palsy.

    Measured: From enrollment to the end of treatment at 6 weeks

  4. Risk Analysis - Adverse Event Incidence Rate

    Records instances of falls and malfunctions or errors of robotic walking devices, assessing the associated risks to ensure safety.

    Measured: From enrollment to the end of treatment at 6 weeks

  5. Rate of change in pain level

    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.

    Measured: From enrollment to the end of treatment at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start2 Sep 2024
  3. Primary completion28 Nov 2024
  4. Study completion28 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
A Single-Arm, Open-label, Pre-Post Comparison Study Design
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05759182
Sponsor's protocol ID
EXO-CIP-001
Status last verified
Jun 2025
First submitted
8 Feb 2023
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17370477

  • 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.

    PubMed 19379288

  • 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.

    PubMed 19207296

  • 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.

    PubMed 11508924

  • 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.

    PubMed 12724591

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

    PubMed 8458127

  • 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.

    PubMed 17094192

  • 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.

    PubMed 17324366

  • 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.

    PubMed 28553117

  • 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.

    PubMed 11321005

  • 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.

    PubMed 14624080

  • 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.

    PubMed 21674390

  • 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.

    PubMed 17476001

  • 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.

    PubMed 17204680

  • 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.

    PubMed 15827916

Questions about this trial

What is this clinical trial studying?

A study testing Powered Exoskeleton Gait Training in people with Cerebral Palsy and Gait Disorders, run by COSMO ROBOTICS CO., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Improved Physical Activity (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05759182, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in