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

64 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Robotic Exoskeleton Therapy for Cerebral Palsy?

Research shows that robotic exoskeleton therapy can help improve balance and walking abilities in children with cerebral palsy. Studies found that this therapy, when combined with other treatments like physical therapy, can lead to better walking speed and motor function. ^{1 2 3 4 5}

Is robotic exoskeleton therapy safe for humans?

Robotic exoskeleton therapy can cause some side effects like skin and tissue discomfort, musculoskeletal issues, and changes in blood pressure. These risks are often due to pressure and misalignment between the robot and the human body, but more detailed safety data and improvements are needed to make these devices safer. ^{2 6 7 8 9}

How is Robotic Exoskeleton Gait Therapy different from other treatments for cerebral palsy?

Robotic Exoskeleton Gait Therapy is unique because it uses a wearable device to provide powered assistance to the lower body, helping children with cerebral palsy improve their walking and balance through repetitive, guided movements. This approach is non-invasive and offers a new option for children who have limited treatment choices, especially those who are non-ambulatory (unable to walk). ^{2 3 7 9 10}

What is the purpose of this trial?

This trial is testing two types of walking exercises for young people with cerebral palsy. One uses regular physical therapy, and the other uses a robotic suit to help them walk. The robotic suit might change brain activity to improve walking ability. The study aims to see which method works better. Robot-assisted gait training has been increasingly implemented in clinical settings to improve walking ability in children with cerebral palsy.

Research Team

Max J Kurz, PhD

Principal Investigator

Father Flanagan's Boys' Home

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Robotic lower extremity exoskeleton use in a non-ambulatory child with cerebral palsy: a case study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effect of robotic-assisted gait rehabilitation on dynamic equilibrium control in the gait of children with cerebral palsy. [2018]

4. Netherlands 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). [2021]

5. Switzerland 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

7. England 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. [2018]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of robotic exoskeletons for improving gait in children with cerebral palsy: A systematic review. [2023]

10. England 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. [2021]