Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

NCT05117827 | Active Not Recruiting FDA Device

• 1 other identifier: 22-052-H
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

For children who use a power wheelchair, a powered wheelchair standing device (PWSD) may be considered for daily use. A PWSD allows a child to electronically move between sitting and standing and can be driven in either position. Existing published PWSD research in pediatrics is limited to boys with Duchenne muscular dystrophy (DMD).(1, 2) While these studies provide some insights into PWSD use in boys with DMD, they do not reflect PWSD use in children with other conditions. The purpose of this exploratory study is to determine the feasibility of a research protocol exploring use of a PWSD in children who have neurodevelopmental conditions other than DMD.

Conditions

Cerebral Palsy; Spinal Muscular Atrophy; Spinal Cord Injuries; Spina Bifida; Development Delay; Genetic Disease

Outcome Measures

Primary Outcomes (1)

• Participation in children

  Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?

  2 years

Secondary Outcomes (2)

• Parental/caregiver perceptions

  2 years

• Children's perceptions

  2 years

Study Arms (1)

Power Wheelchair Standing Device User

EXPERIMENTAL

Device: Power Wheelchair Standing Device

Interventions

Power Wheelchair Standing Device DEVICE

A power wheelchair standing device is a power wheelchair that allows a child to electronically move between sitting and standing. It can be driven in either position. The Permobil F5 Corpus VS is the specific power wheelchair standing device to be used in this study.

Power Wheelchair Standing Device User

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Is 5-17 years of age. NOTE: Participants must be under 18 for the duration of the study.
• Diagnosed with a neurodevelopmental condition resulting in an inability to functionally ambulate.
• Can safely assume and maintain a supported standing position
• Has sufficient upper extremity and function to safely use a PWSD
• Can communicate pain or discomfort through verbalization, vocalization, use of augmented communication, etc.
• Can safely use the PWSD in areas of their home
• Has at least one parent/caregiver who is able to converse in English and actively participate in a device-use education provided in English
• The PerMobil PWSD can be set up to meet the child's specific needs
• Medical Clearance to trial the PWSD
• Participants must reside in Michigan

You may not qualify if:

• Has a diagnosis of Duchenne muscular dystrophy.
• Any reason that it would not be safe for the child to use a PWSD

Sponsors & Collaborators

• Grand Valley State University: lead

Study Sites (1)

Grand Valley State University

Grand Rapids, Michigan, 49501, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscular Atrophy, Spinal; Spinal Cord Injuries; Spinal Dysraphism; Learning Disabilities; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases; Trauma, Nervous System; Wounds and Injuries; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: November 12, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years
• Access Criteria: Contact PI

Locations

US (1)