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
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|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- Participation in children [ Time Frame: 2 years ]Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?
- Parental/caregiver perceptions [ Time Frame: 2 years ]Does using a PWSD influence parental/caregiver perceptions of their child's emotional/behavioral status?
- 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?
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|Ages Eligible for Study:||5 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Has a diagnosis of Duchenne muscular dystrophy.
- Any reason that it would not be safe for the child to use a PWSD
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
|United States, Michigan|
|Grand Valley State University|
|Grand Rapids, Michigan, United States, 49501|
|Responsible Party:||Lisa Kenyon, Professor, Grand Valley State University|
|Other Study ID Numbers:||
|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.|
|Time Frame:||2 years|
|Access Criteria:||Contact PI|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Spinal Cord Injuries
Muscular Atrophy, Spinal
Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Pathological Conditions, Anatomical
Motor Neuron Disease
Neural Tube Defects
Nervous System Malformations