Powered Wheelchair Standing Devices for Developmental Delay

Overseen By Lisa K. Kenyon, PT, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Grand Valley State University

Disqualifiers: Duchenne muscular dystrophy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how children with neurodevelopmental conditions, excluding Duchenne muscular dystrophy, can benefit from a powered wheelchair standing device (PWSD). The PWSD enables children to switch easily between sitting and standing, even while moving. Researchers seek to determine if daily use of this device is practical and safe for these children. Children who cannot walk independently, can stand with support, and can use their arms to control the device might be suitable candidates. Participants must reside in Michigan and have medical clearance to try the PWSD. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their mobility and independence.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this powered wheelchair standing device is safe for children with neurodevelopmental conditions?

Research has shown that powered wheelchair standing devices (PWSDs) have mostly been studied in boys with Duchenne muscular dystrophy (DMD). These studies suggest that using a PWSD can help improve muscle length and reduce stiffness. However, limited information exists on the safety and effectiveness of these devices for children with other conditions.

A small study on PWSD use found no serious safety problems. Still, the overall evidence on safety remains limited, and more research is needed to understand how well these devices work for children with different needs. As this study is exploratory, researchers are still determining the best ways to test these devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Power Wheelchair Standing Device because it offers a novel way to assist individuals with developmental delays. Unlike traditional wheelchairs, which mainly support sitting, this device enables users to stand, potentially improving mobility and independence. The standing feature may also enhance circulation and reduce the risk of pressure sores, offering health benefits beyond what standard wheelchairs provide. By allowing users to switch between sitting and standing, it could significantly enhance quality of life and daily functioning.

What evidence suggests that a powered wheelchair standing device is effective for children with developmental delay?

Research shows that powered wheelchair standing devices (PWSDs) greatly benefit children with mobility challenges. Studies have found that these devices help children improve self-care skills and become more independent. In research focused on PWSDs, participants showed positive results, such as better body posture and increased interaction with their surroundings. Although most studies have examined boys with Duchenne muscular dystrophy, the findings suggest that PWSDs could also assist children with other developmental conditions. Early evidence supports the idea that PWSDs may enhance mobility and quality of life for children who use power wheelchairs. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 5-17 with neurodevelopmental conditions that prevent walking. They must be able to use a powered wheelchair standing device (PWSD), communicate discomfort, and have caregiver support. The child should not have Duchenne muscular dystrophy or any condition making PWSD use unsafe.

Inclusion Criteria

I can safely use a device with my arms and hands.

I have a condition that prevents me from walking.

I can stand up with support.

Exclusion Criteria

I have been diagnosed with Duchenne muscular dystrophy.

Any reason that it would not be safe for the child to use a PWSD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a powered wheelchair standing device (PWSD) to explore its feasibility and impact on participation and perceptions

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Power Wheelchair Standing Device

Trial Overview The study tests the use of a Power Wheelchair Standing Device in children with various neurodevelopmental conditions. It aims to see if it's feasible to conduct research on how these devices are used by kids other than those with Duchenne muscular dystrophy.

How Is the Trial Designed?

Group I: Power Wheelchair Standing Device User Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Grand Valley State University

Lead Sponsor

Trials

13

Recruited

8,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11893569/

The effects of family directed power mobility on self-care ... Power mobility devices (PMD) can help mitigate the negative effects of limited self-directed exploration in children with mobility impairments.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7681349/

Powered mobility interventions for very young children with ... The aim of this study was to find out the benefits and costs of providing very young children, aged < 5 years, with powered mobility devices.

3. tandfonline.com tandfonline.com/doi/full/10.1080/17483107.2022.2120101

Full article: Exploring powered wheelchair standing device ... The purpose of this case series was to explore the influence of powered wheelchair standing device (PWSD) use on participants.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148215000581

Effectiveness of Powered Mobility Devices in Enabling ... To investigate the effectiveness of powered mobility device (ie, powered wheelchair and scooter) interventions over a 1-year period in Nordic countries.

5. researchgate.net researchgate.net/publication/363495211_Exploring_powered_wheelchair_standing_device_use_in_children_and_adults_a_longitudinal_case_series

(PDF) Exploring powered wheelchair standing device use ... The outcomes of this case series may assist both researchers and clinicians when implementing future PWSD studies recommending PWSDs to their ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10036232/

A Systematic Review of Outcomes Measured Following New ... Outcome measures to evaluate wheelchair and seating-system prescription vary, and the use of study-specific outcome-measurement tools is high.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10215286/

Powered Mobility Device Use and Developmental Change ... The purpose of this study was to understand the effect of a powered mobility intervention on developmental changes of children with cerebral palsy (CP).

8. hca.wa.gov hca.wa.gov/assets/program/rapid-review-standing-frames.pdf

Standing Frames: Effectiveness and Safety: Rapid Review ... We found very low strength of evidence for all outcomes related to the effectiveness, safety, and cost-effectiveness of the use of standing frames among ...

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

Stakeholder perspectives of pediatric powered wheelchair ... Such standing programs have been found to improve muscle length, decrease spasticity, prevent contractures, increase peer interaction, and ...