- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05339932
Grand Valley State University (GVSU) Skills on Wheels
September 9, 2025 updated by: Lisa Kenyon, Grand Valley State University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Grand Valley State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Manual wheelchair skills training
|
The intervention involves manual wheelchair skills training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
|
|
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.
|
Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
|
|
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.
|
Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in behavior
Time Frame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
|
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.
|
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
|
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).
|
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
|
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.
|
Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2022
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
March 30, 2022
First Submitted That Met QC Criteria
April 15, 2022
First Posted (Actual)
April 21, 2022
Study Record Updates
Last Update Posted (Estimated)
September 15, 2025
Last Update Submitted That Met QC Criteria
September 9, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Wounds and Injuries
- Congenital Abnormalities
- Neurodevelopmental Disorders
- Trauma, Nervous System
- Brain Damage, Chronic
- Spinal Cord Diseases
- Nervous System Malformations
- Neural Tube Defects
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Genetic Diseases, Inborn
- Cerebral Palsy
- Spinal Cord Injuries
- Spinal Dysraphism
- Motor Skills Disorders
Other Study ID Numbers
- 22-226-H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
De-identified data may be shared upon request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
Clinical Trials on Manual Wheelchair Skills Training
-
University of PittsburghU.S. Department of EducationCompleted
-
Nova Scotia Health AuthorityTerminated
-
KU LeuvenCompleted
-
Nova Scotia Health AuthorityCanadian Institutes of Health Research (CIHR)Completed
-
Laval UniversityNot yet recruitingMyotonic Dystrophy Type 1 | Wheelchair Mobility | ARSACS | Manual Wheelchair Skills TrainingCanada
-
Lee KirbyIWK Health CentreCompleted
-
Nova Scotia Health AuthorityCompleted
-
University of British ColumbiaCompletedConfidence Using a WheelchairCanada
-
Laval UniversityActive, not recruiting
-
US Department of Veterans AffairsCompletedSpinal Cord InjuryUnited States