Robot-Based Gait Training for Cerebral Palsy

Overseen By Matt McGuire, DPT

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Orthopedic surgeries, Musculoskeletal deformities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a robotic device called the CPWalker can improve walking abilities in children and young adults with cerebral palsy. Participants will undergo several training sessions using the CPWalker to determine if it makes walking easier and more efficient. The trial targets individuals diagnosed with spastic diplegia, a type of cerebral palsy, who can walk but face challenges. Participants should be able to follow simple instructions and communicate clearly about any pain or discomfort. Joining this trial could be a valuable opportunity to try a new kind of therapy.

As an unphased trial, this study offers a unique chance to explore innovative therapy options that could enhance mobility and quality of life.

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.

What prior data suggests that the CPWalker is safe for pediatric patients with cerebral palsy?

Research has shown that using robots like the CPWalker to assist people with cerebral palsy in walking is generally safe. One study examined adults with cerebral palsy and found this type of training safe during an 11-day hospital stay. Although this study focused on adults, it suggests that using robots for walking practice presents few safety issues.

For children with cerebral palsy, another study tested robot-assisted walking training and found it could improve walking ability without major safety concerns. While these studies didn't report specific negative effects, participants tolerated the treatments well.

It is important to note that the CPWalker is still undergoing testing to determine its effectiveness for children, so safety information continues to be collected. However, existing research suggests that robot-based training could be a safe way to help children with cerebral palsy improve mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional therapies for cerebral palsy, such as physical therapy and medication, the CPWalker is a robotic-assisted device that offers a unique approach to gait training. This cutting-edge technology allows for precise, repeatable movements tailored to each individual's needs, potentially enhancing motor learning and coordination in ways that manual therapy cannot match. Researchers are excited because the CPWalker could provide more consistent and intensive training, possibly leading to improved mobility outcomes for children with cerebral palsy in a shorter timeframe.

What evidence suggests that the CPWalker is effective for gait training in cerebral palsy?

Studies have shown that robotic-assisted walking training can help children with cerebral palsy improve their walking ability. This training is particularly beneficial for children with diplegic cerebral palsy, as it enhances their walking over time. Although some reviews note that researchers are still learning about its full effects, early results are promising. In this trial, participants will use the CPWalker, a robotic device that supports and guides a child's legs during walking sessions, helping to strengthen muscles and improve movement. Overall, robotic-assisted walking training offers a hopeful new approach to helping kids with cerebral palsy walk better. ^{1 3 6 7 8}

Who Is on the Research Team?

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.

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.

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?

Group I: CPWalker Robotic-Assisted Gait Training Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Gait Training for Individuals With Cerebral Palsy: A Systematic Review and Meta-Analysis. Carvalho, I., Pinto, SM., Chagas, DDV., et al.[2018]

A powered exoskeleton designed for knee extension assistance showed promising results in improving knee extension by 18.1° and total knee range of motion by 21.0° in a six-year-old boy with cerebral palsy and crouch gait.

The device did not significantly reduce knee extensor muscle activity, suggesting that the child was able to use his muscles effectively while benefiting from the exoskeleton, indicating its potential for long-term gait training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Robotic Exoskeleton for Treatment of Crouch Gait in Children With Cerebral Palsy: Design and Initial Application. Lerner, ZF., Damiano, DL., Park, HS., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground Robot-Assisted Gait Training for Pediatric Cerebral Palsy. Kim, SK., Park, D., Yoo, B., et al.[2021]

A wearable exoskeleton was found to be safe and well-tolerated by ambulatory children with cerebral palsy (CP), effectively reducing crouch gait during walking, which is a common and debilitating issue in CP.

The exoskeleton improved knee extensor muscle activity and showed postural improvements in six out of seven participants, with benefits increasing over the course of a multiweek trial, suggesting its potential as a long-term treatment strategy for enhancing mobility in children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lower-extremity exoskeleton improves knee extension in children with crouch gait from cerebral palsy. Lerner, ZF., Damiano, DL., Bulea, TC.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor and robotic assistive gait training for children with cerebral palsy. Pool, D., Valentine, J., Taylor, NF., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10035373/

Is robotic gait training effective for individuals with cerebral ... Robotic-assisted gait training improves walking abilities in diplegic children with cerebral palsy. Eur J Paediatr Neurol. 2017;21(3):557–64. [DOI] [PubMed] ...

2. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-018-0412-9

A robot-based gait training therapy for pediatric population ... Robotic-assisted gait training improves walking abilities in diplegic children with cerebral palsy. Eur J Paediatr Neurol. 2017:1–8. https ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02391324

NCT02391324 | Effectiveness of Robotic Gait Training and ... Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28253887/

Effectiveness of robot-assisted gait training in children with ... Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT).

5. sciencedirect.com sciencedirect.com/science/article/pii/S0966636223014005

Evidence for gait improvement with robotic-assisted ... Robotic-assisted gait training is a promising new treatment in cerebral palsy. •. Effects and significance are not proven yet. •. This review found a tendency ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9918396/

Safety and Feasibility of Robot-assisted Gait Training in Adults ... The aim of the study was to investigate whether RAGT is safe and feasible for adults with CP during an 11-day hospital stay (GMFCS level II and ...

7. clinicaltrial.be clinicaltrial.be/en/details/63878?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Robot Based Gait Training Therapy for Pediatric Populatio... CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy; Performing lower limb ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821278

Overground Gait Training With a Wearable Robot in ... This randomized clinical trial of 90 children with CP found significant improvements in gross motor function, balance control, and gait pattern