Robotic Exoskeleton Therapy for Cerebral Palsy

Recruiting in Palo Alto (17 mi)

Overseen by Max J Kurz, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Father Flanagan's Boys' Home

Disqualifiers: Recent surgery, Metal in body, others

No Placebo Group

Trial Summary

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.

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}

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.

Trial 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 (Behavioural Intervention)
• Robotic Exoskeleton Gait Therapy (Exoskeleton)

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

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]

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]