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Robotic Exoskeleton
Robotic Walking Device for Child Movement Disorders
N/A
Recruiting
Led By Thomas C Bulea, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights
Study Summary
This trial is testing a robotic device worn on the legs to improve walking for people aged 3-17 with a gait disorder. Participants will be tested before and after 12-weeks of walking with the device in the lab, home, and with their regular therapy.
Who is the study for?
Children aged 3-17 with knee-related gait disorders from cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury. They must be able to walk at least 10 feet and commit to the study's duration. Pregnant individuals or those with other conditions affecting walking ability are excluded.Check my eligibility
What is being tested?
The trial tests a pediatric robotic exoskeleton (P.REX/Agilik) designed for children with movement disorders. It involves three phases: standard therapy continuation, lab-based exoskeleton training with customized fitting, and home use of the device for walking practice.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the device, skin irritation where it attaches to the body, muscle fatigue due to exercise mode resistance or possible joint strain during usage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD.
Secondary outcome measures
To evaluate improvement in overground walking of children with CP, SB, iSCI or MD as a function of average gait speed while walking with the robotic exoskeleton
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group AExperimental Treatment1 Intervention
12 weeks-study intervention
Group II: Group BActive Control1 Intervention
12 weeks the control first.
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Who is running the clinical trial?
National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
880,958 Total Patients Enrolled
Thomas C Bulea, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
1 Previous Clinical Trials
85 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no health issues affecting my walking except for cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.I have not had uncontrolled seizures in the last year.I am between 3 and 17 years old.I can move my ankle up and down at least 15 degrees.I can walk at least 10 feet on my own or with help.My knee can move at least 25 degrees and I don't have hamstring issues that would stop me from joining the study.I have walking difficulties due to a knee problem caused by cerebral palsy, muscular dystrophy, spina bifida, or a spinal cord injury.I cannot exercise for 60 minutes or 5 days a week due to a heart or lung condition.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any qualifications for me to participate in this clinical experiment?
"Those afflicted with spina bifida and between the ages of 3 and 17 are eligible for participation in this trial. A total of 44 participants must be enrolled before the study can commence."
Answered by AI
Is this clinical trial accepting participants over the age of 35?
"This medical experiment has established that individuals aged 3 to 17 are the only ones eligible for participation. Currently, there are 237 clinical trials seeking enrolment from minors and 406 additional studies looking for seniors over 65 years of age."
Answered by AI
Is enrollment now open for this medical experiment?
"Data available on clinicaltrials.gov confirms that this trial is not actively recruiting as it was last modified on February 13th, 2023. Despite the lack of current recruitment for this study, there are 627 other medical studies searching for patients presently."
Answered by AI
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