30 Participants Needed

Robot-Based Gait Training for Cerebral Palsy

SP
MM
Overseen ByMatt McGuire, DPT
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Shirley Ryan AbilityLab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if the CPWalker, a robotic device that supports and guides children with cerebral palsy, can help improve their walking ability. The goal is to see if these children can walk better after several training sessions. The CPWalker is a robotic device designed to support and guide children with cerebral palsy, and similar robotic systems have shown effectiveness in improving gait and quality of life in children with CP.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that ongoing botox injections are not allowed.

Is robot-based gait training safe for children with cerebral palsy?

Research shows that robot-based gait training, including the use of wearable exoskeletons, is generally safe and well-tolerated in children with cerebral palsy. Studies report that children were able to walk independently with the device, and it was safe even for those with severe motor impairments.12345

How is the CPWalker treatment different from other treatments for cerebral palsy?

The CPWalker treatment is unique because it uses an untethered exoskeletal robot to assist children with cerebral palsy in walking, providing a realistic walking experience by generating assistive torques during different phases of walking. This approach is different from traditional therapies as it allows for overground walking and adapts to the child's intended movements, potentially improving motor function, walking speed, and endurance.23567

What data supports the effectiveness of the treatment CPWalker for children with cerebral palsy?

Research shows that robot-assisted gait training (RAGT) can improve walking abilities in children with cerebral palsy. Studies found that children who underwent RAGT showed better motor function, walked faster and farther, and used less energy while walking.23567

Who Is on the Research Team?

AJ

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 11-21 with Cerebral Palsy, specifically spastic diplegia. They should weigh no more than 75kg, be between approximately 110cm to 170cm tall, and have a certain level of motor function (GMFCS score of 2-4). Participants must understand verbal instructions and fit the CPWalker's size requirements. Those with recent surgeries, ongoing botox treatments, severe deformities or cognitive impairments that prevent understanding exercises are excluded.

Inclusion Criteria

I can walk but with limitations.
My height is between 110cm and 170cm.
I am between 11 and 21 years old.
See 5 more

Exclusion Criteria

I have wounds or lesions that have not healed.
I have movement issues like uncontrolled movements or trouble with coordination.
You have severe bone or muscle problems that make it hard to wear the exoskeleton safely and comfortably. If you have special braces for your feet, you may still be able to participate if they fit safely in the CPWalker.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline Testing

Baseline testing sessions to assess initial gait parameters and functional mobility

1 week
1 visit (in-person)

Treatment

Participants engage in an 8-week CPWalker training program with 16-24 sessions

8 weeks
16-24 visits (in-person)

Post-training Testing

Post-training testing sessions to evaluate changes in gait and functional mobility

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CPWalker
Trial Overview The study is testing the CPWalker Robotic Exoskeleton as a walking aid for kids with Cerebral Palsy. It aims to see if this technology can help improve their ability to walk. The participants will use the robotic exoskeleton in gait training sessions to assess its effectiveness as an intervention tool.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CPWalker Robotic-Assisted Gait TrainingExperimental Treatment1 Intervention
Each subject will participate in 16-24 gait training sessions in the CPWalker over the course of 8 weeks with each session lasting up to 2 hours

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials
212
Recruited
17,900+

Published Research Related to This Trial

Robotic gait training has positive effects on individuals with cerebral palsy, leading to improvements in walking speed, endurance, and gross motor function, based on a meta-analysis of 10 studies.
The analysis indicated moderate effect sizes for these improvements, suggesting that robotic training can be a beneficial intervention for enhancing mobility in patients classified between levels I and IV of the Gross Motor Function Classification System.
Robotic Gait Training for Individuals With Cerebral Palsy: A Systematic Review and Meta-Analysis.Carvalho, I., Pinto, SM., Chagas, DDV., et al.[2018]
In a study involving 40 children with cerebral palsy, robotic assisted gait training (RAGT) combined with locomotor training did not show significant improvements in mobility outcomes compared to locomotor training alone.
All participants completed the training without any reported adverse events, indicating that both training methods are safe for children with varying levels of mobility in cerebral palsy.
Locomotor and robotic assistive gait training for children with cerebral palsy.Pool, D., Valentine, J., Taylor, NF., et al.[2021]
The pilot study involving three children with bilateral spastic cerebral palsy demonstrated that overground robot-assisted gait training (RAGT) using a torque-assisted exoskeleton significantly improved gross motor function and walking performance after 17-20 training sessions.
All participants showed positive outcomes, including increased walking speed and endurance, with one child achieving independent walking with a platform walker, indicating that this intervention is both safe and effective even for those with severe motor impairments.
Overground Robot-Assisted Gait Training for Pediatric Cerebral Palsy.Kim, SK., Park, D., Yoo, B., et al.[2021]

Citations

Effects of robot-assisted gait training alongside conventional therapy on the development of walking in children with cerebral palsy. [2021]
Robotic Gait Training for Individuals With Cerebral Palsy: A Systematic Review and Meta-Analysis. [2018]
Locomotor and robotic assistive gait training for children with cerebral palsy. [2021]
Overground Robot-Assisted Gait Training for Pediatric Cerebral Palsy. [2021]
Improvement of walking abilities after robotic-assisted locomotion training in children with cerebral palsy. [2014]
A lower-extremity exoskeleton improves knee extension in children with crouch gait from cerebral palsy. [2023]
A Robotic Exoskeleton for Treatment of Crouch Gait in Children With Cerebral Palsy: Design and Initial Application. [2021]
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