What side effects are associated with this type of intervention?

Common treatments for Cerebral Palsy, such as physical therapy, strength training, and exercise therapy, generally have minimal side effects but can include muscle soreness and fatigue. Botulinum toxin injections, used to reduce spasticity, may cause localized pain, weakness, and in rare cases, systemic effects like difficulty swallowing or breathing. Casting can lead to skin irritation and discomfort. Surgical interventions, while potentially beneficial for severe cases, carry risks such as infection, bleeding, and the need for prolonged rehabilitation. Overall, these treatments aim to improve mobility and function with manageable side effects.

What prior FDA approvals exist?

FDA-approved treatments for Cerebral Palsy primarily focus on managing symptoms such as spasticity and dystonia. Common pharmacologic treatments include oral antispasticity medications like baclofen and benzodiazepines, as well as botulinum toxin injections for localized spasticity. Surgical options such as Selective Dorsal Rhizotomy (SDR) and intrathecal baclofen pumps are also used to reduce severe spasticity. These treatments aim to improve motor function, reduce discomfort, and enhance the quality of life for individuals with CP, aligning with the goals of extending rehabilitation benefits and promoting self-care.

What other types of research exist?

Promising, novel alternatives for Cerebral Palsy patients in 2024 include the Hybrid Assistive Limb (HAL) exoskeleton, which has shown improvements in walking functions, and the MotionTherapy@Home device, which offers safe and feasible home-based therapy. These technologies could extend rehabilitation benefits and promote self-care for CP patients.

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Behavioural Intervention

Robotic Training with Auditory Feedback for Cerebral Palsy

N/A

Waitlist Available

Led By Jiyeon Kang

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

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

Must have

Ambulation of a distance of 100 feet with or without the use of assistive devices.

Adults with cerebral palsy (18-65 years old)

Must not have

Surgery within 6 months

Lower limb prosthetics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 5 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if a cable-actuated system can help people with cerebral palsy (CP) improve their locomotion and encourage them to be more independent.

Who is the study for?

This trial is for adults aged 18-65 with cerebral palsy who can walk at least 100 feet, even if they need help from devices. It's not for those with severe foot or knee deformities, recent surgery, pregnancy, lower limb prosthetics, serious lung or heart issues, loss of sensation in limbs, uncontrolled blood pressure, seizures or severe arthritis.

What is being tested?

The study tests a new system that combines robotic gait training with auditory feedback to improve walking ability in people with CP. The goal is to extend the benefits of cable-actuated gait training and support self-care practices at home.

What are the potential side effects?

Potential side effects may include discomfort from wearing the bodyweight augment system or smart insole and fatigue due to exercise during the use of these interventions. Specific side effects will depend on individual tolerance and physical condition.

Eligibility Criteria

Inclusion Criteria

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

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I can walk 100 feet with or without help like a cane.

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I am an adult aged 18-65 with cerebral palsy.

Exclusion Criteria

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

Select...

I have not had surgery in the last 6 months.

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I use a prosthetic for my lower limb.

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I do not have severe respiratory, heart problems, loss of sensation, or uncontrolled blood pressure.

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I have a severe inward twist of my foot or backward bending of my knee.

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I have severe arthritis.

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I have a seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 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

Change of 10m walk between pre/post evaluation and 6 Training sessions

Change of 6 min walk between Pre/post evaluation

Change of Ground reaction force between 6 Training sessions

+2 more

Other study objectives

Change of Muscle tone between Pre/post evaluation

Change of functional gait assessment between Pre/post evaluation

Change of strength of Post evaluation between Pre/post evaluation

+2 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: Adults with Cerebral PalsyExperimental Treatment2 Interventions

Adults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet

0 / 8Eligibility 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) include physical therapy, muscle-tendon surgeries, and functional gait training. Physical therapy aims to improve motor skills and muscle strength through targeted exercises. Muscle-tendon surgeries, such as lengthening or transferring tendons, help to correct deformities and improve function by addressing abnormal muscle actions. Functional gait training focuses on enhancing walking ability and speed through repetitive practice and specific exercises. Treatments like the Platform for Cable-Actuated Gait Training extend these benefits by providing continuous, adaptive support, encouraging self-care, and promoting long-term improvements in mobility. These treatments are crucial for CP patients as they enhance functional independence, improve quality of life, and reduce the risk of secondary complications.

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