Standing Wheelchair for Spina Bifida

Overseen By Patricia McCraken, DPT, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Optimal Mobility, Inc

Disqualifiers: Trunk control, Limb contracture, Orthopedic surgery, Pressure injuries, Seizures, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of wheelchair designed to help kids with spina bifida stand up and move around more easily. Researchers aim to evaluate how well this standing wheelchair, called PedMMSWC, performs in various settings, such as labs and simulated home and school environments. Kids aged 8 to 17 who primarily use a manual wheelchair and participate in a standing program might be suitable candidates. The goal is to improve mobility and ease of use compared to current wheelchairs. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative solutions that could significantly enhance daily life for kids with spina bifida.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical criteria and abilities rather than medication use.

What prior data suggests that the PedMMSWC is safe for children with spina bifida?

Research has shown that devices like the PedMMSWC, which help children stand while in a wheelchair, are generally safe and beneficial. Other studies found that children using similar wheelchairs improved their skills and self-esteem. These devices are already recommended for spina bifida care. This evidence suggests that the PedMMSWC is likely safe and well-tolerated for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PedMMSWC standing wheelchair for spina bifida because it offers a unique approach to mobility. Unlike traditional wheelchairs, this device allows users to stand, which can improve circulation, bone health, and overall independence. The wheelchair's design focuses on maneuverability and ease of use in various settings, from labs to simulated community environments. This adaptability and potential health benefits set it apart from standard mobility aids, sparking interest in its potential to enhance the quality of life for individuals with spina bifida.

What evidence suggests that the PedMMSWC is effective for spina bifida?

Research has shown that standing programs can improve muscle flexibility and movement in children with myelomeningocele, a severe form of spina bifida. This trial tests the PedMMSWC, a new type of standing wheelchair, to enhance these benefits by enabling users to stand and move simultaneously. In Experiment 1, participants will perform tasks in a laboratory setting to assess the maneuverability and ease of use of the PedMMSWC compared to commercial devices. Experiment 2 will involve tasks in simulated home, school, and community settings using the PedMMSWC. Early findings from these tests are encouraging, suggesting it may be easier to use and maneuver in various settings, potentially aiding daily mobility tasks better than traditional wheelchairs. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking kids aged 8-17 with Spina Bifida who use a manual wheelchair and are part of a standing program. They must fit the new wheelchair's size limits, be able to follow instructions, and not have had recent surgery or conditions that make standing unsafe.

Inclusion Criteria

Are able to speak and read in English

I am between 8 and 17 years old.

Are actively enrolled in a standing program

Exclusion Criteria

Have pressure injuries at the location where the PedMMSWC interfaces

I cannot stand due to a contracture in my lower limb.

I struggle with tasks requiring fine motor skills, like standing up from a seated position without help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

In-Lab Testing

Perform tasks in a laboratory environment designed to test the maneuverability and ease of use of the PedMMSWC as compared to commercial devices

1 day

1 visit (in-person)

Simulated Community and Home Testing

Perform tasks in a simulated home, school, and community setting using the PedMedWC wheelchair

1-2 days

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PedMMSWC

Trial Overview

The study tests a new type of pediatric wheelchair (PedMMSWC) designed for children with mobility issues. It involves user testing and simulated use in environments like home, school, and community to assess its benefits.

How Is the Trial Designed?

Group I: Experiment 2: Simulated Community and Home Testing Experimental Treatment 1 Intervention

Perform tasks in a simulated home, school, and community setting using the PedMedWC wheelchair.

Group II: Experiment 1: In-Lab Testing Experimental Treatment 1 Intervention

Perform tasks in a laboratory environment designed to test the maneuverability and ease of use of the PedMMSWC as compared to commercial devices.

Who Is Running the Clinical Trial?

Optimal Mobility, Inc

Lead Sponsor

Gillette Children's Specialty Healthcare

Collaborator

Trials

31

Recruited

8,100+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07290556

Establishing the Preliminary Utility of a Novel Pediatric ...

The primary outcome measure for this aim is user performance on a modified Wheelchair Skills Test (mWST) under three test conditions: PedMMSWC ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12525406/

Effects of a Standing Program for Ambulatory Children with ...

Conclusions: Personalized standing programs may improve muscle flexibility and functional movement quality in ambulatory children with MMC.

3.

trial.medpath.com

trial.medpath.com/clinical-trial/637f27d5c1d84453/nct07290556-pediatric-manual-mobile-standing-wheelchair

Establishing the Preliminary Utility of a Novel Pediatric Manual ...

The primary outcome measure for this aim is user performance on a modified Wheelchair Skills Test (mWST) under three test conditions: PedMMSWC ...

4.

researchgate.net

researchgate.net/publication/351970509_Outcomes_of_a_child-based_manual_wheelchair_skills_peer_training_program_an_exploratory_case_report

Outcomes of a child-based manual wheelchair skills peer ...

Purpose: The purpose of this exploratory case series was to describe the outcomes for both a child-learner and a child-peer after a single ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/dmcn.14842

Stakeholder perspectives of pediatric powered wheelchair ...

Aim. To explore and describe the experiences and perspectives of various stakeholders regarding the use of powered wheelchair standing ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34048664/

Outcomes of a child-based manual wheelchair skills peer ...

Conclusions: Both the participants in this exploratory case appeared to demonstrate improvements in MWC skills, self-esteem, and self-image ...

7.

journals.sagepub.com

journals.sagepub.com/doi/10.3233/PRM-200744

Mobility guidelines for the care of people with spina bifida

If the child is not pulling to stand, consider using a standing frame or mobility device to get him or her upright and weight bearing. Clinical consensus. 3.