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Grand Valley State University (GVSU) Skills on Wheels

Primary Purpose

Spina Bifida, Cerebral Palsy, Genetic Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Wheelchair Skills Training
Sponsored by
Grand Valley State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spina Bifida

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Grand Valley State UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manual wheelchair skills training

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
March 30, 2022
Last Updated
June 30, 2023
Sponsor
Grand Valley State University
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1. Study Identification

Unique Protocol Identification Number
NCT05339932
Brief Title
Grand Valley State University (GVSU) Skills on Wheels
Official Title
GVSU Skills on Wheels: A Pediatric Manual Wheelchair Skills Training Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grand Valley State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida, Cerebral Palsy, Genetic Disease, Spinal Cord Injuries, Gross Motor Development Delay, Motor Skills Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual wheelchair skills training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Manual Wheelchair Skills Training
Intervention Description
The intervention involves manual wheelchair skills training.
Primary Outcome Measure Information:
Title
Change in manual wheelchair skills performance
Description
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
Title
Change in manual wheelchair skill performance
Description
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
Title
Change in manual wheelchair skill confidence
Description
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 Outcome Measure Information:
Title
Change in behavior
Description
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
Title
Change in adaptive skills
Description
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
Title
Changes in perceptions regarding the manual wheelchair skills intervention
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Kenyon, PhD
Phone
616-331-5653
Email
kenyonli@gvsu.edu
Facility Information:
Facility Name
Grand Valley State University
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa K Kenyon, PT, DPT, PhD
Phone
616-331-5653
Email
kenyonli@gvsu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified data may be shared upon request.

Learn more about this trial

Grand Valley State University (GVSU) Skills on Wheels

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