Pediatric Powered Wheelchair Standing Devices: An Explora... | NCT05117827

Studies
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

NCT05117827

Sponsor

Grand Valley State University

Status

Active, not recruiting

Last Update Posted

Sep 15, 2025Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

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

Interventions

Power Wheelchair Standing Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 12, 2021Actual

Primary Completion Date

Oct 31, 2026Estimated

Completion Date

Oct 31, 2027Estimated

First Submitted Date

Nov 1, 2021

First Submission Date that Met QC Criteria

Nov 1, 2021

First Posted Date

Nov 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2025

Last Update Posted Date

Sep 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Power Wheelchair Standing Device User	Experimental		Device: Power Wheelchair Standing Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participation in children	Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?	2 years

Secondary Outcomes

Measure	Description	Time Frame
Parental/caregiver perceptions	Does using a PWSD influence parental/caregiver perceptions of their child's emotional/behavioral status?	2 years
Children's perceptions	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?

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grand Valley State University		Grand Rapids	Michigan	49501	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol

Time Frame

2 years

Access Criteria

Contact PI

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D009134	Muscular Atrophy, Spinal
D013119	Spinal Cord Injuries
D016135	Spinal Dysraphism
D007859	Learning Disabilities
D030342	Genetic Diseases, Inborn

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided