Robotic Exoskeleton Therapy for Cerebral Palsy

Overseen By Max J Kurz, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Father Flanagan's Boys' Home

Disqualifiers: Recent surgery, Metal in body, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with cerebral palsy (CP) improve their walking. It compares traditional physical therapy with a high-tech option involving a robotic exoskeleton, a wearable device that assists movement. Participants will undergo a series of tests before and after an 8-week therapy period to evaluate the treatments' effectiveness. The trial seeks adolescents and young adults with a cerebral palsy diagnosis who have not had recent orthopedic surgery.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform CP treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this robotic exoskeleton therapy is safe for cerebral palsy patients?

Research has shown that robotic exoskeleton therapy is generally safe for people with cerebral palsy. One study on wearable exoskeletons found them safe for patients with neurological issues. Another study focused on a device called the ATLAS 2030 and found it safe for children with cerebral palsy.

These studies suggest that robotic exoskeletons are well-tolerated, with no major safety concerns. Side effects or problems are rare and not serious. Participants in these studies generally responded well to the therapy, making it a promising option for improving movement and strength. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Robotic Exoskeleton Gait Therapy for cerebral palsy because it offers a novel approach compared to traditional physical therapy. Unlike conventional treatments that rely on manual exercises, this therapy uses a robotic exoskeleton to provide precise, controlled movements that can improve walking patterns. The exoskeleton's ability to deliver consistent and repeatable gait training could lead to more efficient and potentially faster improvements in mobility for youth and young adults with cerebral palsy. This technology-driven approach represents a significant advancement in enhancing rehabilitation outcomes.

What evidence suggests that this trial's treatments could be effective for cerebral palsy?

Research shows that robotic exoskeleton therapy, which participants in this trial may receive, can significantly help people with cerebral palsy improve their walking. Studies have found that after using a robotic exoskeleton, participants walked more smoothly and covered more distance. One study found that children with cerebral palsy improved their movement skills, balance, and overall walking style. Other research noted that this therapy can help people walk faster and take longer steps while using less energy. These improvements can lead to better mobility and a higher quality of life for those affected. Meanwhile, another group in this trial will receive physical therapy, serving as an active comparator to evaluate the effectiveness of the robotic exoskeleton therapy. ^{2 6 7 8 9}

Who Is on the Research Team?

Max J Kurz, PhD

Principal Investigator

Father Flanagan's Boys' Home

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults with cerebral palsy who haven't had orthopedic surgery in the last 6 months or any metal in their body that would interfere with MRI scans. Participants should not have other neurodevelopmental conditions like autism, Down Syndrome, or ADHD.

Inclusion Criteria

I have been diagnosed with Cerebral Palsy.

You do not have conditions like autism, Down Syndrome, or ADHD.

You do not have any known atypical brain development, such as autism, Down syndrome, or ADHD.

Exclusion Criteria

You don't have any metal in your body that would prevent you from having an MRI.

I haven't had any bone surgery in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete MEG brain imaging, MRI spinal cord imaging, neurophysiological tests, and clinical mobility assessments

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo 8 weeks of gait therapy using either traditional physical therapy or a robotic exoskeleton

8 weeks

8 visits (in-person)

Post-Treatment Assessment

Participants repeat the same assessments completed at baseline to evaluate therapeutic outcomes

1-2 weeks

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

• Physical Therapy
• Robotic Exoskeleton Gait Therapy

Trial Overview The study compares traditional physical therapy to robotic exoskeleton gait training for improving walking abilities. Participants will undergo brain imaging, spinal cord tests, and mobility assessments before and after completing the gait training protocol.

How Is the Trial Designed?

Group I: Cerebral Palsy Youth/Young Adults Robotic Exoskeleton Experimental Treatment 1 Intervention

Baseline and 8 week assessments; 8 week gait therapy using robotic exoskeleton

Group II: Cerebral Palsy Youth/Young Adults Physical Therapy Active Control 1 Intervention

Baseline and 8 week assessments; 8 week gait therapy

Who Is Running the Clinical Trial?

Father Flanagan's Boys' Home

Lead Sponsor

Trials

14

Recruited

1,600+

Published Research Related to This Trial

In a study involving 10 children with cerebral palsy, walking on the Lokomat exoskeleton resulted in lower muscle activity compared to treadmill walking, indicating that the Lokomat may not fully engage the muscles as effectively during gait training.

Adjusting training parameters like speed can increase muscle activity in the Lokomat, suggesting that to enhance training effectiveness, it may be beneficial to encourage higher speeds or provide specific instructions to promote active contributions from the children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amplitude and stride-to-stride variability of muscle activity during Lokomat guided walking and treadmill walking in children with cerebral palsy. van Kammen, K., Reinders-Messelink, HA., Elsinghorst, AL., et al.[2021]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

Robot-assisted gait training (RAGT) using the Hybrid Assistive Limb (HAL) showed a positive impact on gait parameters in pediatric patients with cerebral palsy, particularly in the Gross Motor Function Measure (GMFM), with significant improvements in specific dimensions of motor function.

While RAGT did not lead to significant differences in walking speed compared to the control group, it provided motivation for patients to practice walking, suggesting potential benefits in therapy when combined with traditional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Robot-Assisted Gait Training in Pediatric Patients with Cerebral Palsy in an Inpatient Setting-A Randomized Controlled Trial. Moll, F., Kessel, A., Bonetto, A., et al.[2022]

Children with cerebral palsy had mixed feelings about robotic gait training with the Lokomat, often feeling uncertain about what to expect and sometimes anxious about participating, indicating a need for better engagement strategies in rehabilitation.

Despite the potential benefits of robotic training, children did not express a strong desire to achieve 'normal' walking patterns, suggesting that rehabilitation goals should align more closely with children's personal expectations and experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Phelan, SK., Gibson, BE., Wright, FV.[2018]

Robotic exoskeletons can significantly improve gait in children with cerebral palsy by enhancing walking speed, reducing the metabolic cost of walking, and promoting normal ankle function, as shown in a systematic review of 13 studies.

The effectiveness of these exoskeletons is maximized when there is careful optimization of torque and adequate practice time for each child, highlighting the need for future studies to focus on larger controlled trials with sufficient adaptation periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of robotic exoskeletons for improving gait in children with cerebral palsy: A systematic review. Hunt, M., Everaert, L., Brown, M., et al.[2023]

Robotic-assisted gait training using the Lokomat® Pediatric significantly improved locomotor parameters and balance control in children with Cerebral Palsy, as shown by a study involving 14 treated children compared to 16 control children.

The therapy resulted in a more appropriate timing between the Center of Mass and Center of Pressure trajectories, indicating enhanced gait mechanics after 20 sessions of rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of robotic-assisted gait rehabilitation on dynamic equilibrium control in the gait of children with cerebral palsy. Wallard, L., Dietrich, G., Kerlirzin, Y., et al.[2018]

A 7-year-old girl with cerebral palsy used the Trexo Home robotic gait trainer for an average of 46 minutes per week over 3.3 days, leading to an increase in bowel movement frequency from 0.4 to 1.2 per day.

While there were no significant changes in overall postural stability or range of motion, improvements were noted in head control and knee flexor spasticity, suggesting potential benefits of robotic gait training for non-ambulatory children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic lower extremity exoskeleton use in a non-ambulatory child with cerebral palsy: a case study. Diot, CM., Thomas, RL., Raess, L., et al.[2023]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

A meta-analysis of eight studies involving 188 individuals with cerebral palsy found that robotic gait training did not significantly improve mobility compared to standard care methods like physical therapy.

The study assessed various mobility outcomes, including walking speed and endurance, and concluded that tethered robotic devices do not offer additional benefits over traditional treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is robotic gait training effective for individuals with cerebral palsy? A systematic review and meta-analysis of randomized controlled trials. Conner, BC., Remec, NM., Lerner, ZF.[2023]

Outpatient robot-assisted gait training (RAGT) did not show significant improvements in walking abilities for 16 children with spastic cerebral palsy after five weeks of treatment, indicating it may not be effective as a standalone intervention.

The study suggests that RAGT should be part of a comprehensive treatment plan, as it alone cannot address all aspects of gait improvement, and emphasizes the importance of personalized rehabilitation goals and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT). Ammann-Reiffer, C., Bastiaenen, CHG., Meyer-Heim, AD., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12368361/

Exoskeleton therapy in cerebral palsy: improved gait ... Following the exoskeleton training, participants demonstrated a statistically significant improvement in gait efficiency, with 6MWT distances increasing from ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07049523

Robotic Exoskeleton Gait Training for Children With ... The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0966636222005914

Effectiveness of robotic exoskeletons for improving gait in ... Robotic exoskeletons have the potential to improve the mobility of CP children and may therefore increase community participation and improve quality of life.

4. 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

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12458414/

A Systematic Review of Robotic Exoskeletons for Cerebral Palsy Exoskeleton studies showed notable improvements in gait speed (up to 0.51 m/s), stride length, and knee extension (by 13.8°), while also reducing the energy ...

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

Safety and Feasibility of Robot-assisted Gait Training in Adults ... We hypothesize that RAGT with HAL during a 11-day therapy inpatient stay can be delivered feasible and safe in adult patients with CP. It might ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674413/

Usability and Safety of the ATLAS 2030 Robotic Gait ... The purpose of this study was to evaluate the safety and usability of the ATLAS 2030 in children with Cerebral Palsy (CP) and Spinal Muscular Atrophy (SMA).

8. mdpi.com mdpi.com/2075-4426/13/4/676

Effects and Safety of Wearable Exoskeleton for Robot ... Overground RAGT using wearable devices can improve muscle strength, balance, and gait function. It is safe in patients with neurologic injury.

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1651913/pdf

Protocol for the “stand the future” trial: robotic exoskeleton ... This protocol describes a trial designed to evaluate the effects of a 6-month robotic gait training intervention on gross motor function, ...