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Robot-assisted Therapy
Robot-assisted Training for Cerebral Palsy
N/A
Recruiting
Led By Christos Papadelis, PhD
Research Sponsored by Cook Children's Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
An evaluation by a pediatric neurologist, Physical Medicine and Rehabilitation (PMNR) physicians (physiatrists), neonatal developmental specialist, or neonatologist with a diagnosis of CP
Classified as high-functioning (I or II) at the Gross Motor Function Classification System (GMFCS)
Must not have
History of trauma or brain operation
Psychoactive or myorelaxant medication during study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 15, day 60
Awards & highlights
Summary
This trial aims to find new ways to help children with cerebral palsy improve their motor functions using robot-assisted rehabilitation. The goal is to help children with this condition improve their movement abilities and overall quality
Who is the study for?
This trial is for children with Cerebral Palsy, a condition affecting movement and coordination. Specific eligibility criteria are not provided, but typically such trials require participants to have a certain level of motor function and no other health conditions that could interfere with the treatment.
What is being tested?
The study is testing robot-assisted training using a device called Amadeo. The goal is to see if this high-tech tool can help improve motor skills in children with CP by providing them with advanced rehabilitation exercises.
What are the potential side effects?
While specific side effects are not listed, robot-assisted training may cause fatigue or muscle soreness due to repetitive movements during rehabilitation sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CP by a specialist.
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I have good mobility and can move without much help.
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I have never had a brain injury or neurological disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a brain surgery or injury in the past.
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I am not taking any psychoactive or muscle relaxant medications during the study.
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I have been diagnosed with a genetic syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 15, day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 15, day 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assisting Hand Assessment (AHA)
Force
Hand motion trajectory (aiming & pointing test)
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group IIExperimental Treatment1 Intervention
Participants in this group will be between the ages of 7 and 18 years old and have no history of neurological disorder or brain injury. Amadeo will be used to train the non-dominant hand of participants in this group. The training will last approximately 1 hour per day for 14 successive days. Participants will be asked to first do active finger and passive finger moving, then receive haptic vibration, and finally play interactive games.
Group II: Experimental Group IExperimental Treatment1 Intervention
Participants in this group will be between the ages of 7 and 18 years old and have a diagnosis of cerebral palsy. Amadeo will be used to train the more-affected hand of participants in this group. The training will last approximately 1 hour per day for 14 successive days. Participants will be asked to first do active finger and passive finger moving, then receive haptic vibration, and finally play interactive games.
Group III: Control Group IActive Control1 Intervention
Participants in this group will be between the ages of 7 and 18 years old and have a diagnosis of cerebral palsy.
Group IV: Control Group IIActive Control1 Intervention
Participants in this group will be between the ages of 7 and 18 years old and have no history of neurological disorder or brain injury.
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Who is running the clinical trial?
Cook Children's Health Care SystemLead Sponsor
9 Previous Clinical Trials
5,000,779 Total Patients Enrolled
Christos Papadelis, PhDPrincipal InvestigatorCook Children's Health Care System
3 Previous Clinical Trials
84 Total Patients Enrolled
1 Trials studying Cerebral Palsy
32 Patients Enrolled for Cerebral Palsy
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