Clinical trial NCT05339932: Grand Valley State University (GVSU) Skills on Wheels
Official title: GVSU Skills on Wheels: A Pediatric Manual Wheelchair Skills Training Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spina Bifida
Cerebral Palsy
Genetic Disease
Spinal Cord Injuries
Gross Motor Development Delay
Motor Skills Disorders
Lead sponsor: Grand Valley State University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 4
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in manual wheelchair skills performance
timeFrame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
measure: Change in manual wheelchair skill performance
timeFrame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
measure: Change in manual wheelchair skill confidence
timeFrame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Secondary outcomes:
measure: Change in behavior
timeFrame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
measure: Change in adaptive skills
timeFrame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
measure: Changes in perceptions regarding the manual wheelchair skills intervention
timeFrame: Baseline,pre-intervention and immediately after the conclusion of the 6 week intervention
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Grand Valley State University
state: Michigan
Study officials:
References: