What side effects are associated with this type of intervention?

Common treatments for Cerebral Palsy, such as physical and occupational therapy, generally have minimal side effects but can include temporary muscle soreness and fatigue. Botulinum toxin injections, used to reduce spasticity, may cause transient pain at the injection site, mild flu-like symptoms, and in rare cases, muscle weakness. Surgical interventions, like tendon lengthening or selective dorsal rhizotomy, carry risks such as infection, bleeding, and prolonged recovery periods. Robotic exoskeleton gait training, while still under study, may involve discomfort from device fit and temporary muscle soreness as patients adapt to the new movement patterns.

What prior FDA approvals exist?

FDA-approved treatments for cerebral palsy primarily focus on managing spasticity and improving motor function. These include oral antispasticity medications like baclofen and benzodiazepines, botulinum toxin injections for localized spasticity, and various physical and occupational therapies. While robotic exoskeletons are an emerging technology being studied for their potential to assist and enhance gait training by providing mechanical support and movement guidance, specific FDA approvals for these devices in the treatment of cerebral palsy are not detailed in the provided context.

What other types of research exist?

Promising, novel alternatives to robotic exoskeletons for gait training in cerebral palsy patients include: 1) Constraint-Induced Movement Therapy (CIMT), which promotes motor and sensory function by encouraging the use of the affected limb through restraint of the unaffected limb. 2) Context-Focused Therapy, which enhances task performance by modifying the task or environment. 3) Goal-Directed/Functional Training, which focuses on activities based on goals set by the child using a motor-learning approach. 4) Transcranial Magnetic Stimulation (TMS), which shows potential in modulating brain activity to improve motor function. 5) Mind-Body Therapies such as yoga and Qigong massage, which may improve motor skills, balance, and overall well-being.

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Exoskeleton

Robotic Exoskeleton Therapy for Cerebral Palsy

N/A

Recruiting

Led By Max J Kurz, PhD

Research Sponsored by Father Flanagan's Boys' Home

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cerebral Palsy diagnosis for Cerebral Palsy participants

Be younger than 65 years old

Must not have

No orthopedic surgery in the last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (cp and neurotypical) and 8 weeks (cp)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two types of walking exercises for young people with cerebral palsy. One uses regular physical therapy, and the other uses a robotic suit to help them walk. The robotic suit might change brain activity to improve walking ability. The study aims to see which method works better. Robot-assisted gait training has been increasingly implemented in clinical settings to improve walking ability in children with cerebral palsy.

Who is the study for?

This trial is for adolescents and young adults with cerebral palsy who haven't had orthopedic surgery in the last 6 months or any metal in their body that would interfere with MRI scans. Participants should not have other neurodevelopmental conditions like autism, Down Syndrome, or ADHD.

What is being tested?

The study compares traditional physical therapy to robotic exoskeleton gait training for improving walking abilities. Participants will undergo brain imaging, spinal cord tests, and mobility assessments before and after completing the gait training protocol.

What are the potential side effects?

While specific side effects are not detailed here, participants may experience discomfort from physical exertion during therapy sessions or potential skin irritation from wearing the robotic exoskeleton.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Cerebral Palsy.

Exclusion Criteria

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

Select...

I haven't had any bone surgery in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (cp and neurotypical) and 8 weeks (cp)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (cp and neurotypical) and 8 weeks (cp)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (cp and neurotypical) and 8 weeks (cp) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Brain Activity in Sensory Cortices

Change in Hoffmann Reflex

Change in Isolation of Movement

+6 more

Secondary study objectives

Cognitive related changes induced via physical therapy - Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Questionnaire

Cognitive related changes induced via physical therapy - Child and Adolescent Sleep Checklist (CASC)

Cognitive related changes induced via physical therapy - D2 - Test of Attention

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cerebral Palsy Youth/Young Adults Robotic ExoskeletonExperimental Treatment1 Intervention

Baseline and 8 week assessments; 8 week gait therapy using robotic exoskeleton

Group II: Cerebral Palsy Youth/Young Adults Physical TherapyActive Control1 Intervention

Baseline and 8 week assessments; 8 week gait therapy

0 / 2Eligibility 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

The most common treatments for Cerebral Palsy (CP) aim to improve motor function and quality of life by addressing muscle tone, strength, and coordination. Physical and occupational therapy (PT/OT) enhance motor skills and daily functioning through repetitive, task-specific exercises. Constraint-induced movement therapy (CIMT) improves motor function in the affected limb by restraining the unaffected limb, encouraging use of the weaker side. Context-focused therapy adapts tasks or environments to promote successful task performance. Goal-directed/functional training sets specific motor goals to improve targeted activities. Robotic exoskeletons, similar to these therapies, provide mechanical support and movement guidance, enhancing gait training by enabling repetitive, precise movements. These treatments are crucial for CP patients as they help maximize functional independence and improve overall quality of life.

Functional and surgical treatments in patients with spinal muscular atrophy (SMA).Improved gait parameters after robotic-assisted locomotor treadmill therapy in a 6-year-old child with cerebral palsy.