CompletedNot Applicable

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

South Korea10 participantsStarted 2024-09-02

Plain-language 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.

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Improved Physical Activity

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

Score on Gross Motor Function Measure (GMFM)

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

Classification Level on Gross Motor Function Classification System (GMFCS)

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

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

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

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

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

Score on Pediatric Evaluation of Disability Inventory (PEDI)

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

Trial details

NCT IDNCT05759182

SponsorCOSMO ROBOTICS CO., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-28

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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.

What they're measuring

Number of Participants with Improved Physical Activity

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

Score on Gross Motor Function Measure (GMFM)

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

Classification Level on Gross Motor Function Classification System (GMFCS)

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

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

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

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

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

Score on Pediatric Evaluation of Disability Inventory (PEDI)

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