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Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

Primary Purpose

Cerebral Palsy, Spinal Muscular Atrophy, Spinal Cord Injuries

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Power Wheelchair Standing Device
Sponsored by
Grand Valley State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grand Valley State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Power Wheelchair Standing Device User

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parental/caregiver perceptions
Does using a PWSD influence parental/caregiver perceptions of their child's emotional/behavioral status?
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?

Full Information

First Posted
November 1, 2021
Last Updated
February 18, 2023
Sponsor
Grand Valley State University
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1. Study Identification

Unique Protocol Identification Number
NCT05117827
Brief Title
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
Official Title
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grand Valley State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spinal Muscular Atrophy, Spinal Cord Injuries, Spina Bifida, Development Delay, Genetic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Power Wheelchair Standing Device User
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Power Wheelchair Standing Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participation in children
Description
Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Parental/caregiver perceptions
Description
Does using a PWSD influence parental/caregiver perceptions of their child's emotional/behavioral status?
Time Frame
2 years
Title
Children's perceptions
Description
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?
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Grand Valley State University
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

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