Establishing the Preliminary Utility of a Novel Pediatric Manual Mobile Standing Wheelchair

NCT ID: NCT07290556

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-01

Study Completion Date

2027-08-25

Brief Summary

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To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).

Detailed Description

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Conditions

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Spina Bifida

Keywords

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Spinal Bifida Wheelchair Pediatric Standing

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Experiment 1: 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.

Group Type EXPERIMENTAL

PedMMSWC Wheelchair User Testing

Intervention Type DEVICE

The PedMMSWC standing wheelchair prototype will be tested and compared with a standing frame during Experiment 1: In-Lab Testing.

Experiment 2: Simulated Community and Home Testing

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

Group Type EXPERIMENTAL

PedMMSWC Simulated Home, School, Community Environment

Intervention Type DEVICE

The PedMMSWC standing wheelchair will be tested in a simulated home, school, and community environment. Participants will be given assigned tasks and be scored on completion of activities.

Interventions

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PedMMSWC Wheelchair User Testing

The PedMMSWC standing wheelchair prototype will be tested and compared with a standing frame during Experiment 1: In-Lab Testing.

Intervention Type DEVICE

PedMMSWC Simulated Home, School, Community Environment

The PedMMSWC standing wheelchair will be tested in a simulated home, school, and community environment. Participants will be given assigned tasks and be scored on completion of activities.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 8 - 17 years old
* Primarily use a manual wheelchair for daily mobility
* Are actively enrolled in a standing program
* Fit the height and weight requirements of the PedMMSWC
* Can follow simple verbal instructions
* Are able to speak and read in English

Exclusion Criteria

* Have insufficient trunk control to maneuver in seated and standing positions
* Have lower limb contracture which would preclude standing
* Have had orthopedic surgery within the last twelve months
* Have pressure injuries at the location where the PedMMSWC interfaces
* Have insufficient fine motor skills to independently initiate the sit-to-stand function
* Have a history of uncontrolled seizures or cardiovascular conditions that would make participation unsafe
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gillette Children's Specialty Healthcare

OTHER

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role collaborator

Optimal Mobility, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Patricia McCraken, DPT, MBA

Role: CONTACT

Phone: 320-247-2104

Email: [email protected]

Facility Contacts

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Mark Jankowski

Role: primary

Related Links

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https://optimal-mobility.com/

Company (sponsor) Website

Other Identifiers

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R44HD118822

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00086649

Identifier Type: -

Identifier Source: org_study_id