ClinicalTrials.gg
Active, not recruitingNCT05339932Updated Sep 15, 2025

Grand Valley State University (GVSU) Skills on Wheels

An interventional study of Manual Wheelchair Skills Training in Spina Bifida, Cerebral Palsy and Genetic Disease, sponsored by Grand Valley State University. Active, not recruiting at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Grand Valley State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
5 Years to 17 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Spina Bifida
  • Cerebral Palsy
  • Genetic Disease
  • Spinal Cord Injuries
  • Gross Motor Development Delay
  • Motor Skills Disorders
03

In context

Spinal Dysraphism

142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.

This study's planned enrollment of 4 is below the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.

Browse Spinal Dysraphism studies →

Lead sponsor

Grand Valley State University is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • Experimental
    Manual wheelchair skills training

    Other: Manual Wheelchair Skills Training

Interventions

  • OtherManual Wheelchair Skills Training

    The intervention involves manual wheelchair skills training.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention

  2. 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.

    Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention

  3. 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.

    Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention

Secondary outcomes

  1. 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.

    Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention

  2. 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).

    Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention

  3. 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.

    Time frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — De-identified data may be shared upon request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Nov 2026, 54 months after the start.

Of 60 non-industry interventional studies with no phase under Spinal Dysraphism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's planned 54 months is above that.

Counting every sponsor, half of 62 studies reached it within 31 months; a quarter within 20 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2022
First posted
Apr 21, 2022
StartActual
May 5, 2022
Primary completionEst.
Nov 30, 2026
CompletionEst.
Dec 31, 2027
Last update
Sep 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05339932
Lead sponsor
Grand Valley State University
Responsible party
Lisa Kenyon (Professor, Grand Valley State University) — Principal investigator
First posted
Apr 21, 2022
Start date
May 5, 2022
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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