Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

Cerebral Palsy Clinical Trial

Official title:

Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05117827
• Other study ID #: 22-052-H
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Grand Valley State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Development Delay
• Genetic Disease
• Genetic Diseases, Inborn
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Spina Bifida
• Spinal Cord Injuries
• Spinal Dysraphism
• Spinal Muscular Atrophy

Intervention

Device:
• Power Wheelchair Standing 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.

Locations

Country	Name	City	State
United States	Grand Valley State University	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Grand Valley State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation in children	Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?	2 years
Secondary	Parental/caregiver perceptions	Does using a PWSD influence parental/caregiver perceptions of their child's emotional/behavioral status?	2 years
Secondary	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?	2 years