Spina BifidaNCT05339932
Grand Valley State University (GVSU) Skills on Wheels
A study testing Manual Wheelchair Skills Training in people with Spina Bifida and Cerebral Palsy, run by Grand Valley State University at 1 site in United States.
Trial summary
Manual wheelchairs (MWCs) are widely used by children with physical disabilities, yet many of these children are unable to use their wheelchair independently. Instead, they depend on others to push them. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Spina Bifida, Cerebral Palsy, Genetic Disease
- What is being tested?
- Manual Wheelchair Skills Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2022to 31 Dec 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
- 5-17 years of age. NOTE: Participants must be under 18 for the duration of the study.
- Have a condition resulting in difficulties walking.
- Use a manual wheelchair greater than or equal to 25% of the time
- Are able to follow simple instructions per parent report
- Has at least one parent/caregiver who is able to converse in English (as assessed by the PI during interactions over the phone and in person) due to safety concerns.
- Resides in Michigan
Who cannot join
- Any reason that it would not be safe for the child to participate in manual wheelchair training (as assessed by the PI, a licensed physical therapist)
- The child's manual wheelchair is not safe (as assessed by the PI, a licensed physical therapist)
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Valley State University
Grand Rapids, Michigan, 49503
About this study
Official title: GVSU Skills on Wheels: A Pediatric Manual Wheelchair Skills Training Program
Manual wheelchairs (MWCs) are widely used by children with physical disabilities, yet many of these children are unable to use their wheelchair independently. Instead, they depend on others to push them. This dependency results in limited opportunities to decide what they want to do and where they want to go, leading to learned helplessness, social isolation, decreased participation, and restricted involvement in physical activities. Furthermore, unsafe MWC use increases the risk of injury, as highlighted by the 44,300 children treated each year in emergency departments for MWC-related injuries. While independent MWC mobility can positively influence quality of life, MWC skills training must also be provided to promote safe, independent MWC use. The effectiveness of MWC training programs for adults is well established, yet the current standard-of-care does not include MWC skills training for children and research regarding the efficacy of pediatric MWC skills training programs is limited. Skills on Wheels seeks to address these gaps and provide pilot data for a future large-scale, multi-site research project involving a randomized controlled trial. Aim 1 is to explore the influence of Skills on Wheels on children's MWC skills and confidence in their MWC use. Aim 2 is to investigate the influence of Skills on Wheels on children's psychosocial skills, social participation, and adaptive behavior.
Read the detailed description
Manual wheelchairs (MWCs) are widely used by children with physical disabilities, yet many of these children are unable to use their wheelchair independently. Instead, they depend on others to push them. This dependency results in limited opportunities to decide what they want to do and where they want to go, leading to learned helplessness, social isolation, decreased participation, and restricted involvement in physical activities. Furthermore, unsafe MWC use increases the risk of injury, as highlighted by the 44,300 children treated each year in emergency departments for MWC-related injuries. While independent MWC mobility can positively influence quality of life, MWC skills training must also be provided to promote safe, independent MWC use. The effectiveness of MWC training programs for adults is well established, yet the current standard-of-care does not include MWC skills training for children and research regarding the efficacy of pediatric MWC skills training programs is limited. Skills on Wheels seeks to address these gaps and provide pilot data for a future large-scale, multi-site research project involving a randomized controlled trial. The final outcomes and significance of this project are as follows: Aim 1 is to explore the influence of Skills on Wheels on children's MWC skills and confidence in their MWC use and Aim 2 is to investigate the influence of Skills on Wheels on children's psychosocial skills, social participation, and adaptive behavior.
- Conditions
- Spina Bifida, Cerebral Palsy, Genetic Disease, Spinal Cord Injuries, Gross Motor Development Delay, Motor Skills Disorders
- Being tested
- Manual Wheelchair Skills Training
- Medical subject headings
- Spinal Dysraphism, Cerebral Palsy, Genetic Diseases, Inborn, Spinal Cord Injuries, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Wheelchair Skills TrainingOther
The intervention involves manual wheelchair skills training.
| Study group | Role | What they receive |
|---|---|---|
| Manual wheelchair skills training | Experimental | Not described Receives: Other: Manual Wheelchair Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in manual wheelchair skills performance
This outcome will be assessed using the Wheelchair Skills Test (WST) and the Wheelchair Skills Test Questionnaire (WST-Q) scales for performance. These complementary measures were designed to be used together and consist of a 0-3 rating scale for each of the 32 manual wheelchair skills included in these measures.
Measured: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Change in manual wheelchair skill performance
This outcome will be assessed using the Canadian Occupational Performance Measure (COPM) to identify, prioritize,and rate caregiver perceptions of children's performance of manual wheelchair skills and will provide the basis for manual wheelchair skills training intervention. A total of 4-5 occupational performance issues in the area of manual wheelchair skills will be identified and scored on a 1-10 scale for both the caregiver's perception of the child's performance and their satisfaction with the child's performance. This completed with children >8-years-old, if they are able.
Measured: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Change in manual wheelchair skill confidence
This outcome will be assessed using the WheelConPed. This measure consists of a 0-4 rating skill for each of the 33 manual wheelchair use scenarios included in the measure.
Measured: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Secondary outcomes (3)
Change in behavior
This outcome will be measured using the Strengths and Difficulties Questionnaire (SDQ) caregiver questionnaire covering children's behaviors and emotions. The SDQ encompasses 5 subscales: Emotional, Conduct, Hyperactivity/inattention, Peer relationships, and Prosocial behavior. The self-report version will also be completed by children ages 11-17, if they are able.
Measured: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Change in adaptive skills
This outcome will be measured using the Adaptive Behavior Assessment System, 3rd Edition (ABAS), a computer-based caregiver questionnaire to assess children's abilities in 11 adaptive skill areas within 3 domains (conceptual, social, and practical).
Measured: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Changes in perceptions regarding the manual wheelchair skills intervention
Caregivers' perceptions of the manual wheelchair skills intervention will be gathered via a recorded qualitative interview. An interview guide has been developed for this purpose. Children will also participate in a recorded qualitative interview, if able. An interview guide has been developed for this purpose.
Measured: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start5 May 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies 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 (estimated)
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
- NCT05339932
- Sponsor's protocol ID
- 22-226-H
- Status last verified
- Sep 2025
- First submitted
- 30 Mar 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data may be shared upon request.
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
- GVSU Skills on Wheels: A Pediatric Manual Wheelchair Skills Training Program
- ClinicalTrials.gov ID
- NCT05339932
- Acronym / sponsor ID
- 22-226-H
- Conditions
- Spina Bifida, Cerebral Palsy, Genetic Disease, Spinal Cord Injuries, Gross Motor Development Delay, Motor Skills Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Grand Valley State UniversityUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Apr 2022 (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.
Manual wheelchairs (MWCs) are widely used by children with physical disabilities, yet many of these children are unable to use their wheelchair independently. Instead, they depend on others to push them. This dependency results in limited opportunities to decide what they want to do and where they want to go, leading to learned helplessness, social isolation, decreased participation, and restricted involvement in physical activities. Furthermore, unsafe MWC use increases the risk of injury, as highlighted by the 44,300 children treated each year in emergency departments for MWC-related injuries. While independent MWC mobility can positively influence quality of life, MWC skills training must also be provided to promote safe, independent MWC use. The effectiveness of MWC training programs for adults is well established, yet the current standard-of-care does not include MWC skills training for children and research regarding the efficacy of pediatric MWC skills training programs is limited. Skills on Wheels seeks to address these gaps and provide pilot data for a future large-scale, multi-site research project involving a randomized controlled trial. Aim 1 is to explore the influence of Skills on Wheels on children's MWC skills and confidence in their MWC use. Aim 2 is to investigate the influence of Skills on Wheels on children's psychosocial skills, social participation, and adaptive behavior.
Detailed description
Manual wheelchairs (MWCs) are widely used by children with physical disabilities, yet many of these children are unable to use their wheelchair independently. Instead, they depend on others to push them. This dependency results in limited opportunities to decide what they want to do and where they want to go, leading to learned helplessness, social isolation, decreased participation, and restricted involvement in physical activities. Furthermore, unsafe MWC use increases the risk of injury, as highlighted by the 44,300 children treated each year in emergency departments for MWC-related injuries. While independent MWC mobility can positively influence quality of life, MWC skills training must also be provided to promote safe, independent MWC use. The effectiveness of MWC training programs for adults is well established, yet the current standard-of-care does not include MWC skills training for children and research regarding the efficacy of pediatric MWC skills training programs is limited. Skills on Wheels seeks to address these gaps and provide pilot data for a future large-scale, multi-site research project involving a randomized controlled trial. The final outcomes and significance of this project are as follows: Aim 1 is to explore the influence of Skills on Wheels on children's MWC skills and confidence in their MWC use and Aim 2 is to investigate the influence of Skills on Wheels on children's psychosocial skills, social participation, and adaptive behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual wheelchair skills training | Experimental | Other: Manual Wheelchair Skills Training |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 5-17 years of age. NOTE: Participants must be under 18 for the duration of the study.
- Have a condition resulting in difficulties walking.
- Use a manual wheelchair greater than or equal to 25% of the time
- Are able to follow simple instructions per parent report
- Has at least one parent/caregiver who is able to converse in English (as assessed by the PI during interactions over the phone and in person) due to safety concerns.
Key exclusion criteria (2 listed)
- Any reason that it would not be safe for the child to participate in manual wheelchair training (as assessed by the PI, a licensed physical therapist)
- The child's manual wheelchair is not safe (as assessed by the PI, a licensed physical therapist)
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 |
|---|---|---|
| Manual Wheelchair Skills TrainingThe intervention involves manual wheelchair skills training. | Other | Manual wheelchair skills training |
Primary outcome
Change in manual wheelchair skills performance
Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
This outcome will be assessed using the Wheelchair Skills Test (WST) and the Wheelchair Skills Test Questionnaire (WST-Q) scales for performance. These complementary measures were designed to be used together and consist of a 0-3 rating scale for each of the 32 manual wheelchair skills included in these measures.
Change in manual wheelchair skill performance
Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
This outcome will be assessed using the Canadian Occupational Performance Measure (COPM) to identify, prioritize,and rate caregiver perceptions of children's performance of manual wheelchair skills and will provide the basis for manual wheelchair skills training intervention. A total of 4-5 occupational performance issues in the area of manual wheelchair skills will be identified and scored on a 1-10 scale for both the caregiver's perception of the child's performance and their satisfaction with the child's performance. This completed with children >8-years-old, if they are able.
Change in manual wheelchair skill confidence
Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
This outcome will be assessed using the WheelConPed. This measure consists of a 0-4 rating skill for each of the 33 manual wheelchair use scenarios included in the measure.
3 secondary outcomes
Change in behavior
Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Change in adaptive skills
Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Changes in perceptions regarding the manual wheelchair skills intervention
Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
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: Undecided. De-identified data may be shared upon request.
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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 Manual Wheelchair Skills Training in people with Spina Bifida and Cerebral Palsy, 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 6 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?
Change in manual wheelchair skills performance (time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention). The study lists 3 primary outcomes in all. 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.