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Robotic Exoskeleton
Robot-Based Gait Training for Cerebral Palsy
N/A
Recruiting
Led By Arun Jayaraman, PT, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gross Motor Function Classification System score of 2-4
Height range of approximately 110cm to 170cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline selective voluntary motor control at 8 weeks
Awards & highlights
Study Summary
This trial is testing if a CPWalker can help kids with cerebral palsy walk better.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the device, skin irritation where it touches the body, muscle fatigue due to exercise during therapy sessions, and possible pain if pre-existing conditions like unhealed wounds are aggravated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk but with limitations.
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My height is between 110cm and 170cm.
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I am between 11 and 21 years old.
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I can communicate my pain and follow simple instructions.
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I have been diagnosed with Cerebral Palsy, specifically spastic diplegia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline gait speed at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline gait speed at 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10-Meter Walk Test
Secondary outcome measures
6-Minute Walk Test
Child and Adolescent Scale of Participation
GAITRite Data Collection
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CPWalker Robotic-Assisted Gait TrainingExperimental Treatment1 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
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,882 Total Patients Enrolled
6 Trials studying Cerebral Palsy
325 Patients Enrolled for Cerebral Palsy
Arun Jayaraman, PT, PhDPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
22 Previous Clinical Trials
2,872 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have wounds or lesions that have not healed.I have movement issues like uncontrolled movements or trouble with coordination.I can walk but with limitations.My height is between 110cm and 170cm.I am between 11 and 21 years old.You weigh more than 75 kilograms.I can communicate my pain and follow simple instructions.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.I am able to understand instructions and interact with study staff.I have been diagnosed with Cerebral Palsy, specifically spastic diplegia.You have a history of behaving in a way that is harmful to yourself or others.I haven't had any bone surgery in the last 3 months or ongoing botox treatments.My lower limbs fit the CPWalker's size requirements.The ability to understand and follow verbal cues is important when you are trying to communicate with someone
Research Study Groups:
This trial has the following groups:- Group 1: CPWalker Robotic-Assisted Gait Training
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 open slots for enrollment in this clinical trial?
"Yes, it is confirmed that this research project is presently recruiting patients. The initial post was made on July 1st 2019 and the new information was uploaded to clinicaltrials.gov on October 24th 2022. This trial needs 30 volunteers from a single medical centre."
Answered by AI
Is eligibility for the trial exclusive to individuals younger than 35 years of age?
"This investigation specifies that participants must be within the age range of 11 and 21. Additionally, there are 140 studies available for those under 18 years old and 26 trials designated to patients over 65."
Answered by AI
Am I eligible to become a participant in this experiment?
"This research initiative is searching for thirty individuals with cerebral palsy aged 11-21. Prospective participants must have the capacity to comprehend and obey verbal instructions, a Gross Motor Function Classification System score of 2-4, maximum weight up to 75kgs, and stand between 110cm–170 cm tall."
Answered by AI
What is the population size of this research project?
"Affirmative, the information found on clinicaltrials.gov reflects this trial's current recruitment status. The protocol was first established on July 1st 2019 and most recently modified October 24th 2022. This research requires 30 individuals at a single medical facility to participate."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Met criteria
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