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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 15, day 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assisting Hand Assessment (AHA)

Force

Hand motion trajectory (aiming & pointing test)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 6Eligibility criteria met