NCT05339932

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
May 2022Dec 2027

First Submitted

Initial submission to the registry

March 30, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

4.6 years

First QC Date

March 30, 2022

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

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

Secondary Outcomes (3)

  • Change in behavior

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

  • Change in adaptive skills

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

  • Changes in perceptions regarding the manual wheelchair skills intervention

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

Study Arms (1)

Manual wheelchair skills training

EXPERIMENTAL
Other: Manual Wheelchair Skills Training

Interventions

The intervention involves manual wheelchair skills training.

Manual wheelchair skills training

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grand Valley State University

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Spinal DysraphismCerebral PalsyGenetic Diseases, InbornSpinal Cord InjuriesMotor Skills Disorders

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and InjuriesNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 21, 2022

Study Start

May 5, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations