- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05117827
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
September 9, 2025 updated by: Lisa Kenyon, Grand Valley State University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49501
- Grand Valley State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Has a diagnosis of Duchenne muscular dystrophy.
- Any reason that it would not be safe for the child to use a PWSD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Power Wheelchair Standing Device User
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation in children
Time Frame: 2 years
|
Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental/caregiver perceptions
Time Frame: 2 years
|
Does using a PWSD influence parental/caregiver perceptions of their child's emotional/behavioral status?
|
2 years
|
|
Children's perceptions
Time Frame: 2 years
|
For children who are able to respond to questions and participate in an interview using either verbal or augmented communication, does using a PWSD influence their own perceptions of their emotional/behavioral status?
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2021
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2027
Study Registration Dates
First Submitted
November 1, 2021
First Submitted That Met QC Criteria
November 1, 2021
First Posted (Actual)
November 11, 2021
Study Record Updates
Last Update Posted (Estimated)
September 15, 2025
Last Update Submitted That Met QC Criteria
September 9, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Wounds and Injuries
- Neuromuscular Diseases
- Neurobehavioral Manifestations
- Neurodegenerative Diseases
- Congenital Abnormalities
- Neurodevelopmental Disorders
- Trauma, Nervous System
- Brain Damage, Chronic
- Spinal Cord Diseases
- Nervous System Malformations
- Neural Tube Defects
- Motor Neuron Disease
- Communication Disorders
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Genetic Diseases, Inborn
- Cerebral Palsy
- Spinal Cord Injuries
- Spinal Dysraphism
- Muscular Atrophy, Spinal
- Learning Disabilities
Other Study ID Numbers
- 22-052-H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The research team may share research data related to study outcomes from this study with other investigators.
If this occurs, the data will not contain identifiable data.
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
Contact PI
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.