What side effects are associated with this type of intervention?

Common treatments for cerebral palsy aimed at improving walking ability include physical therapy (PT), occupational therapy (OT), and surgical interventions such as Selective Dorsal Rhizotomy (SDR). PT and OT are generally safe but can sometimes cause temporary muscle soreness or fatigue. SDR, a surgical procedure to reduce spasticity, can lead to side effects such as weakness, sensory changes, and, in some cases, complications related to the surgery itself, like infections or issues with wound healing. Each treatment's side effects should be carefully considered and discussed with a healthcare provider.

What prior FDA approvals exist?

There are no specific FDA-approved drugs that directly improve walking ability in children with Cerebral Palsy similar to the CPWalker device. Treatments for Cerebral Palsy often include physical therapy, occupational therapy, and sometimes medications like muscle relaxants to manage spasticity. Devices like the CPWalker, which provide support and assistance to improve walking ability, are part of ongoing research and are not yet standard FDA-approved treatments.

What other types of research exist?

Promising alternatives to CPWalker for Cerebral Palsy patients include: 1) Lokomat, a robotic gait training device that provides automated walking therapy; 2) Trexo Plus, a wearable robotic exoskeleton designed for children with mobility impairments; 3) Innowalk, a motorized medical device that enables assisted, guided, and repetitive movement; and 4) EksoGT, an exoskeleton that helps with gait training and rehabilitation. These devices are supported by recent clinical trials and research, showing potential for improving walking ability in Cerebral Palsy patients.

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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

Must not have

Critical motor control alterations such as dystonia, choreoathetosis, or ataxia

Unhealed wounds/lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline gait quality at 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if the CPWalker, a robotic device that supports and guides children with cerebral palsy, can help improve their walking ability. The goal is to see if these children can walk better after several training sessions. The CPWalker is a robotic device designed to support and guide children with cerebral palsy, and similar robotic systems have shown effectiveness in improving gait and quality of life in children with CP.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have movement issues like uncontrolled movements or trouble with coordination.

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I have wounds or lesions that have not healed.

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I am able to understand instructions and interact with study staff.

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I haven't had any bone surgery in the last 3 months or ongoing botox treatments.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline gait speed at 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

10-Meter Walk Test

Secondary study objectives

6-Minute Walk Test

Child and Adolescent Scale of Participation

GAITRite Data Collection

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cerebral Palsy (CP) aim to improve motor function and walking ability. Physical and occupational therapy help strengthen muscles and improve coordination through targeted exercises. Orthotic devices, such as braces and adaptive strollers, provide support and correct alignment to facilitate better movement. Pharmacologic interventions, including anticholinergics, benzodiazepines, and baclofen, reduce muscle spasticity and dystonia, enhancing mobility. Surgical options, like selective dorsal rhizotomy, decrease spasticity by cutting nerve fibers that contribute to muscle tightness. These treatments are crucial for CP patients as they enhance functional independence, reduce pain, and improve overall quality of life.

The Most Cited Original Articles in Brain Imaging of Children With Cerebral Palsy: A Bibliometric Analysis Between 1984 and 2019.