AMESobreRuedas: early power mobility for increasing participation in children with Spinal Muscular Atrophy type I. Protocol of a randomized controlled trial

Abstract

Background Young children with spinal muscular atrophy type I have severe mobility and participation limitations, which can lead to delays in learning and cognitive development. Early powered mobility interventions may help young children with mobility limitations to move, play, and participate in their environment. The aim of this study is to evaluate whether an early power mobility intervention is effective for increasing participation, functional ability, independence, and quality of life of young children diagnosed with SMA type I. Methods AMESobreRuedas is a single-blinded randomized waiting list - controlled clinical trial. The sample (24 children − 10 months-5 years old diagnosed with SMA type I) will be randomly allocated into 2 groups. Experimental group will receive a powered mobility structured intervention 3 times a week for 12 weeks, and 4 weeks of follow-up where the child will be free to use the powered mobility device. Control group (waiting list) will continue with their daily routine and will receive the same intervention once experimental group finishes. The intervention will be family-centered and carried out in the natural environment of the children (home, school and community). Five assessments will be performed: at baseline, weeks 4, 8, 12 and 16. The primary outcomes are participation (YC-PEM); functional ability and independence (PEDI-CAT); and quality of life (PedsQL-Neuromuscular module). Discussion As far as the authors know, this is the first study on early power mobility for children with SMA type I. Therefore, it will provide valuable information about the impact of this type of intervention on improving participation, functional capacity, and quality of life. Besides, families will be involved in the intervention participating, together with the researchers, in the establishment of functional goals and the implementation of the intervention. Finally, early powered mobility could increase the opportunities for children with SMA type I to learn to move independently and participate in their natural context. Trial Registration: The study was registered on ClinicalTrials.gov with ID: NCT05589987 on October 18, 2022.