Cerebral PalsyNCT05117827
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
A study testing Power Wheelchair Standing Device in people with Cerebral Palsy and Spinal Muscular Atrophy, run by Grand Valley State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy, Spinal Muscular Atrophy, Spinal Cord Injuries
- What is being tested?
- Power Wheelchair Standing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2021to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- Has a diagnosis of Duchenne muscular dystrophy.
- Any reason that it would not be safe for the child to use a PWSD
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Valley State University
Grand Rapids, Michigan, 49501
About this study
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.
- Conditions
- Cerebral Palsy, Spinal Muscular Atrophy, Spinal Cord Injuries, Spina Bifida, Development Delay, Genetic Disease
- Being tested
- Power Wheelchair Standing Device
- Medical subject headings
- Cerebral Palsy, Muscular Atrophy, Spinal, Spinal Cord Injuries, Spinal Dysraphism, Learning Disabilities, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Wheelchair Standing DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Power Wheelchair Standing Device User | Experimental | Not described Receives: Device: Power Wheelchair Standing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in children
Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?
Measured: 2 years
Secondary outcomes (2)
Parental/caregiver perceptions
Does using a PWSD influence parental/caregiver perceptions of their child's emotional/behavioral status?
Measured: 2 years
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?
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start12 Nov 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Valley State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Kenyon, Grand Valley State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117827
- Sponsor's protocol ID
- 22-052-H
- Status last verified
- Sep 2025
- First submitted
- 1 Nov 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
- ClinicalTrials.gov ID
- NCT05117827
- Acronym / sponsor ID
- 22-052-H
- Conditions
- Cerebral Palsy, Spinal Muscular Atrophy, Spinal Cord Injuries, Spina Bifida, Development Delay, Genetic Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Grand Valley State UniversityUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Power Wheelchair Standing Device User | Experimental | Device: Power Wheelchair Standing Device |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- Has a diagnosis of Duchenne muscular dystrophy.
- Any reason that it would not be safe for the child to use a PWSD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power Wheelchair Standing DeviceA 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. | Device | Power Wheelchair Standing Device User |
Primary outcome
Participation in children
Time frame: 2 years
Does using a PWSD increase participation in children who have neurodevelopmental conditions other than DMD?
2 secondary outcomes
Parental/caregiver perceptions
Time frame: 2 years
Children's perceptions
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Wheelchair Standing Device in people with Cerebral Palsy and Spinal Muscular Atrophy, run by Grand Valley State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in children (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.