Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

Not Applicable

Active, not recruiting

• Conditions: Genetic Disease; Development Delay; Cerebral Palsy; Spina Bifida; Spinal Muscular Atrophy; Spinal Cord Injuries
• Interventions: Device: Power Wheelchair Standing Device

• Registration Number: NCT05117827
• Lead Sponsor: Grand Valley State University

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 available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Study Start: 2021-11-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Power Wheelchair Standing Device User	Power Wheelchair Standing Device	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Grand Valley State University; 🇺🇸 Grand Rapids, Michigan, United States