What side effects are associated with this type of intervention?

Common treatments for cerebral palsy that focus on improving mobility and muscle activity, such as physical therapy, occupational therapy, and orthotic devices, generally have minimal side effects. Physical and occupational therapies may cause temporary muscle soreness or fatigue. Orthotic devices, while beneficial for improving gait and joint alignment, can sometimes lead to skin irritation or discomfort if not properly fitted. Overall, these treatments are considered safe and are essential for enhancing functional outcomes in individuals with CP.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Cerebral Palsy that directly match the functionality of the Robotic Ankle Assist Device (RAAD). However, treatments for CP often include physical and occupational therapy, which aim to improve motor function and mobility. Devices such as orthotics and other assistive technologies are commonly used to support these therapies. Additionally, botulinum toxin injections and intrathecal baclofen pumps are FDA-approved treatments that help manage spasticity in CP patients, indirectly aiding in improved mobility and muscle function.

What other types of research exist?

Promising alternatives to the Robotic Ankle Assist Device (RAAD) for Cerebral Palsy patients include: 1) Robotic-assisted treadmill therapy, which has shown improvements in gait parameters, function, speed, and endurance in children with CP. 2) Virtual reality-based motor training platforms, which provide engaging and specific motor skill development. 3) Functional electrical stimulation (FES) devices, which stimulate muscle contractions to improve motor function and mobility. These alternatives offer targeted therapy and have demonstrated positive outcomes in clinical trials.

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Robotic Ankle Assist Device for Cerebral Palsy

Phase 1

Waitlist Available

Led By Ray Browning, PhD

Research Sponsored by BiOMOTUM, Inc.

Eligibility Criteria Checklist

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

Must have

At least 20 degrees of passive ankle plantar flexion range of motion

Age between 8-18 years

Must not have

Knee extension or ankle dorsiflexion contractures greater than 15 degrees

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 minutes pre/post

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a robotic device that helps move the ankle to improve walking. It targets children with Cerebral Palsy who have difficulty walking. The device either helps the ankle push off the ground or provides resistance to strengthen muscles. Researchers hope this will help children walk faster and farther. The use of robotic devices for ankle rehabilitation in children with cerebral palsy has been explored in various studies, showing potential benefits in improving ankle mobility and walking ability.

Who is the study for?

This trial is for children aged 8-18 with cerebral palsy who can follow simple instructions and walk for at least six minutes. They should be within the typical height, weight, or BMI range for their condition and able to do some heel raises. Those with recent surgeries or other health issues that could interfere are not eligible.

What is being tested?

The study tests a Robotic Ankle Assist Device (RAAD) designed to improve walking speed and distance in kids with CP. It includes personal-use trials, feedback collection for product design, comparison of RAAD therapy against standard gait training, and a 4-week intervention assessing mobility improvements.

What are the potential side effects?

While specific side effects aren't listed, potential risks may include discomfort from wearing the device or muscle fatigue due to new types of movement during therapy sessions.

Eligibility Criteria

Inclusion Criteria

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

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I can move my ankle downwards at least 20 degrees.

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I am between 8 and 18 years old.

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My height, weight, and BMI are within the typical range for children with CP.

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I can do 5 heel raises with little help for balance.

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I have been diagnosed with cerebral palsy.

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I can walk for 6 minutes, with or without help.

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I can walk with or without limitations.

Exclusion Criteria

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

Select...

My knee or ankle cannot fully straighten, bending more than 15 degrees.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of the study visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of the study visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the study visit 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 lower extremity muscle activity similarity to the average unimpaired activity pattern

Change in preferred walking speed

PF activity

Secondary study objectives

6MWT

Ankle muscle co-contraction

COT

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: User testingExperimental Treatment1 Intervention

Two sessions of user-centric testing.

Group II: Therapist-guided trainingExperimental Treatment1 Intervention

Therapist-guided gait training with the RAAD.

Group III: Therapist supervised resistance trainingExperimental Treatment1 Intervention

Resistance training with the RAAD under therapist supervision.

Group IV: Parent supervised resistance trainingExperimental Treatment1 Intervention

Resistance training under parent supervision.

Group V: Assistance trainingExperimental Treatment1 Intervention

Assistance training with the RAAD

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) focus on improving mobility and muscle function. Physical and occupational therapy enhance motor skills through repetitive, goal-directed activities. Botulinum toxin injections reduce spasticity by blocking nerve signals to muscles, improving movement and reducing pain. Robotic-assisted devices, such as the Robotic Ankle Assist Device (RAAD), provide targeted therapy by assisting and resisting movements, which strengthens muscles and improves gait. These treatments are essential for CP patients as they address motor impairments, enhance mobility, and improve overall quality of life.

Effects of upper limb robot-assisted therapy on motor recovery of subacute stroke patients: a kinematic approach.Improved gait parameters after robotic-assisted locomotor treadmill therapy in a 6-year-old child with cerebral palsy.