What side effects are associated with this type of intervention?

Common treatments for cerebral palsy, such as physical and occupational therapies, generally have minimal side effects but can sometimes lead to temporary muscle soreness or fatigue. The use of powered wheelchairs and assistive devices like the IndieTrainer system can improve mobility and independence but may require extended training periods, during which users might experience frustration or discomfort. Additionally, improper use or poor fit of these devices can lead to skin irritation or pressure sores. Overall, these treatments are considered safe and beneficial when properly supervised and tailored to the individual's needs.

What prior FDA approvals exist?

The FDA has approved several treatments for managing symptoms of cerebral palsy, primarily focusing on spasticity and motor function improvement. These include oral antispasticity medications like baclofen and benzodiazepines, botulinum toxin injections for localized spasticity, and intrathecal baclofen pumps for severe cases. While there are no specific FDA-approved treatments that directly match the IndieTrainer system's approach of converting manual wheelchairs to powered ones and using video games for skill training, adaptive devices and robotic-assisted therapies are emerging as promising complementary options. These technologies aim to enhance mobility and motor skills in children with CP, similar to the goals of the IndieTrainer system.

What other types of research exist?

Promising alternatives to the IndieTrainer system for Cerebral Palsy patients include: 1) Robotic exoskeletons, which provide support and enhance mobility through powered assistance. 2) Virtual reality (VR)-based rehabilitation programs that offer immersive environments for practicing motor skills and improving coordination. 3) Adaptive gaming systems that use motion-sensing technology to engage patients in therapeutic exercises. 4) Smart wheelchairs equipped with advanced sensors and AI to assist with navigation and obstacle avoidance. These alternatives leverage cutting-edge technology to improve mobility and independence for Cerebral Palsy patients.

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IndieTrainer System for Cerebral Palsy

Q: What is the mechanism of action of this treatment?

The IndieTrainer system for Cerebral Palsy (CP) combines power mobility training with video games to enhance mobility and independence. This approach uses motor learning and neuroplasticity principles, where repetitive, task-specific training improves motor function and coordination. Video games make the training engaging and motivating, crucial for sustained participation. Similar to physical and occupational therapy, which focus on improving motor skills, balance, and functional independence, these treatments significantly enhance quality of life by promoting autonomy, reducing care burden, and enabling participation in various activities.

N/A

Waitlist Available

Research Sponsored by Grand Valley State University

Eligibility Criteria Checklist

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

Must have

Has a diagnosis of cerebral palsy or similar conditions with functional abilities consistent with a Gross Motor Classification System Classification System Level IV or Level V

Does not have an individually prescribed powered wheelchair

Must not have

The child and his/her manual wheelchair or adaptive stroller combined must weigh <300 pounds to safely use the IndieTrainer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline-pre-intervention and immediately after the conclusion of the intervention period,

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the IndieTrainer system, which helps children with cerebral palsy practice using powered wheelchairs. The system converts their manual wheelchair and uses video games for training. It aims to make learning these skills easier and more fun.

Who is the study for?

This trial is for children aged 5-21 with cerebral palsy who can't move their manual wheelchair by themselves and don't have a power wheelchair. They must be using a manual wheelchair or stroller that fits the IndieTrainer system, and weigh less than 300 pounds combined with it. Children with progressive conditions like muscular dystrophy can't join.

What is being tested?

The study tests the IndieTrainer system, which turns a regular manual wheelchair into a powered one. It includes video games that help kids practice moving around in their wheelchairs while playing. The goal is to see if this makes it easier for them to learn how to use power wheelchairs.

What are the potential side effects?

Since this trial involves training equipment rather than medication, traditional side effects are not expected. However, there may be risks associated with using the adapted equipment such as discomfort or injury from improper use.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have cerebral palsy or a similar condition and need significant assistance with mobility.

Select...

I do not own a custom-made powered wheelchair.

Select...

I cannot move a manual wheelchair by myself.

Exclusion Criteria

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

Select...

My child and their wheelchair or stroller together weigh less than 300 pounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline-pre-intervention, immediately after the conclusion of the intervention period, and at the single session retention trial 4 weeks after the end of the intervention period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline-pre-intervention, immediately after the conclusion of the intervention period, and at the single session retention trial 4 weeks after the end of the intervention period

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline-pre-intervention, immediately after the conclusion of the intervention period, and at the single session retention trial 4 weeks after the end of the intervention period 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 power mobility skill performance

Change in power mobility skills performance

Change in understanding how to use a power mobility device

Secondary study objectives

Changes in perceptions regarding the IndieTrainer system intervention

Parent/caregiver satisfaction with the IndieTrainer system

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: Single arm: All participants receive the interventionExperimental Treatment1 Intervention

All participants receive power wheelchair skills training using the IndieTrainer system.

0 / 4Eligibility 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 IndieTrainer system for Cerebral Palsy (CP) combines power mobility training with video games to enhance mobility and independence. This approach uses motor learning and neuroplasticity principles, where repetitive, task-specific training improves motor function and coordination. Video games make the training engaging and motivating, crucial for sustained participation. Similar to physical and occupational therapy, which focus on improving motor skills, balance, and functional independence, these treatments significantly enhance quality of life by promoting autonomy, reducing care burden, and enabling participation in various activities.