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IndieTrainer System for Cerebral Palsy

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline-pre-intervention and immediately after the conclusion of the intervention period,
Awards & highlights

Study Summary

This trialwill evaluate the use of a system (IndieTrainer) to help severely impaired children learn to use powered wheelchairs, so they can participate in activities.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in power mobility skill performance
Change in power mobility skills performance
Change in understanding how to use a power mobility device
Secondary outcome measures
Changes in perceptions regarding the IndieTrainer system intervention
Parent/caregiver satisfaction with the IndieTrainer system

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.

Find a Location

Who is running the clinical trial?

Grand Valley State UniversityLead Sponsor
12 Previous Clinical Trials
8,654 Total Patients Enrolled
4 Trials studying Cerebral Palsy
48 Patients Enrolled for Cerebral Palsy

Media Library

IndieTrainer system Clinical Trial Eligibility Overview. Trial Name: NCT05473182 — N/A
Cerebral Palsy Research Study Groups: Single arm: All participants receive the intervention
Cerebral Palsy Clinical Trial 2023: IndieTrainer system Highlights & Side Effects. Trial Name: NCT05473182 — N/A
IndieTrainer system 2023 Treatment Timeline for Medical Study. Trial Name: NCT05473182 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to partake in this experiment?

"This trial is accepting a maximum of 25 children aged between 5 and 21 with cerebral palsy. To be eligible, patients need to have functional abilities that meet the Gross Motor Classification System (GMFCS) Level IV or V criteria, must not possess an individualized powered wheelchair, and should use either manual wheelchairs or adaptive strollers compatible with IndieTrainer systems as evaluated by the principal investigator. Furthermore, at least one parent/caregiver has to able to converse in English for safety reasons."

Answered by AI

How many participants are currently engaged in this therapeutic trial?

"Correct. Documentation available on clinicaltrials.gov verifies that this experimental trial, which was inaugurated on August 15th 2022, is still recruiting participants. Approximately 25 volunteers must be gathered from 1 medical facility."

Answered by AI

Does this clinical trial feature a minimum age requirement?

"Patients hoping to be included in this trial must fall within the 5-21 age range. For minors, 140 studies are available and 26 for those over 65 years of age."

Answered by AI

Has recruitment for this scientific experiment begun?

"According to the information catalogued on clinicaltrials.gov, this clinical trial is currently in a recruitment phase and was initially published on August 15th 2022. The last edit made to it's data occurred October 14th of the same year."

Answered by AI
~1 spots leftby Jun 2024