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Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05117827
Recruitment Status : Active, not recruiting
First Posted : November 11, 2021
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Lisa Kenyon, Grand Valley State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Spinal Muscular Atrophy Spinal Cord Injuries Spina Bifida Development Delay Genetic Disease Device: Power Wheelchair Standing Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
Actual Study Start Date : November 12, 2021
Actual Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Power Wheelchair Standing Device User 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.


Outcome Measures
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Primary Outcome Measures :
  1. Participation in children [ Time Frame: 2 years ]
    Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?


Secondary Outcome Measures :
  1. Parental/caregiver perceptions [ Time Frame: 2 years ]
    Does using a PWSD influence parental/caregiver perceptions of their child's emotional/behavioral status?

  2. 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?


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117827


Locations
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United States, Michigan
Grand Valley State University
Grand Rapids, Michigan, United States, 49501
Sponsors and Collaborators
Grand Valley State University
More Information
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Responsible Party: Lisa Kenyon, Professor, Grand Valley State University
ClinicalTrials.gov Identifier: NCT05117827    
Other Study ID Numbers: 22-052-H
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: 2 years
Access Criteria: Contact PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Spinal Cord Injuries
Cerebral Palsy
Muscular Atrophy
Muscular Atrophy, Spinal
Spinal Dysraphism
Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
 Brain Diseases
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities