Clinical trial NCT05589987: Spinal Muscular Atrophy on Wheels, Using Power Mobility
Official title: Community's Participation of Children With Spinal Muscular Atrophy Using Power Mobility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Muscular Atrophy
Keywords: home
family
natural environment
participation
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups: experimental and control groups.
Primary purpose: TREATMENT

Brief summary: The group of children diagnosed with Spinal Muscular Atrophy (SMA) has serious restrictions on participation. SMA is a neuromuscular disease that leads to neuromusculoskeletal disorders that limit functional activities, sometimes making it impossible to sit down autonomously and to walk.

Scientific evidence has highlighted the importance of implementing physiotherapy interventions in pediatrics that facilitate the integration and participation of children with reduced mobility in their natural environment through the use of different assisted mobility devices that allow the child to acquire a degree of independence and motivation according to their potential and needs.

For some time, with the aim of offering independent movement opportunities for children with severe motor impairment, adapted electric cars have been used, as they are simple to use and easy for the child and family to incorporate into daily tasks within natural environments. These low-cost motorized devices can generate a very positive impact on the participation of children diagnosed with SMA type I from an early age, after training the family and/or the child himself, guaranteeing the maximum possible safety, comfort, motivation and autonomy.

Due to the above, there is a need to carry out the research project defined below, to generate opportunities for the inclusion of children diagnosed with SMA type I through the use of low-cost electric cars that encourage their participation, motivation and quality of life.

Detailed description: OBJECTIVES

1. To know the acceptability of an intervention with motorized mobility through electric cars for young children diagnosed with SMA type I.
2. To check the effectiveness of the motorized mobility intervention with electric cars with respect to: (a) mobility and (b) participation of young children with SMA type I with respect to the control group of children who do not use such devices.
3. To identify the barriers and facilitators of the child's participation in their natural environment of a motorized mobility intervention with electric cars in young children with SMA type I.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of SMA type I
* Ages between 10 months to 5 years.
* No previous experience with motorized mobility.

Exclusion Criteria:

* severe visual problems
* Associated disorders that do not correspond to the diagnosis of SMA type I.
* Families who do not agree to have training in the use of the electric car and continuous monitoring by the corresponding researcher.

Primary outcomes:
measure: QUEST (Version 2.0) Quebec User Evaluation of Satisfaction with assistive Technology
timeFrame: baseline and Change from basaline at week 12
measure: YC-PEM (Young Children's Participation & Environment Measure)
timeFrame: baseline, Change from basaline at week 12 and Change from basaline at week 16
measure: Pediatric Evaluation of Disability Inventory-Computer Adaptive-test (PEDI-CAT)
timeFrame: baseline, Change from basaline at week 12 and Change from basaline at week 16
measure: Photovoice
timeFrame: baseline,Change from basaline at week 12
Secondary outcomes:
measure: Goal Attainment Scaling (GAS)
timeFrame: baseline, Change from basaline at week 12
measure: Switch Activation
timeFrame: at the end of week 4, 8, and week 12
measure: Daily driving journal
timeFrame: baseline, week 12 and week 16
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Rocío Castilla-La Palomo-Carrión
state: Castilla-La Mancha/Toledo
city: Toledo
country: Spain
facility: University of Castilla-La Mancha
Study officials:
References:
citation: Arnold WD, Kassar D, Kissel JT. Spinal muscular atrophy: diagnosis and management in a new therapeutic era. Muscle Nerve. 2015 Feb;51(2):157-67. doi: 10.1002/mus.24497. Epub 2014 Dec 16.
citation: Livingstone R, Field D. Systematic review of power mobility outcomes for infants, children and adolescents with mobility limitations. Clin Rehabil. 2014 Oct;28(10):954-64. doi: 10.1177/0269215514531262. Epub 2014 Apr 24.
citation: Feldner HA, Logan SW, Galloway JC. Why the time is right for a radical paradigm shift in early powered mobility: the role of powered mobility technology devices, policy and stakeholders. Disabil Rehabil Assist Technol. 2016 Feb;11(2):89-102. doi: 10.3109/17483107.2015.1079651. Epub 2015 Sep 4.
citation: Ostensjo S, Carlberg EB, Vollestad NK. The use and impact of assistive devices and other environmental modifications on everyday activities and care in young children with cerebral palsy. Disabil Rehabil. 2005 Jul 22;27(14):849-61. doi: 10.1080/09638280400018619.
citation: Demers L, Weiss-Lambrou R, Ska B. Item analysis of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). Assist Technol. 2000;12(2):96-105. doi: 10.1080/10400435.2000.10132015.
citation: St John BM, Hladik E, Romaniak HC, Ausderau KK. Understanding health disparities for individuals with intellectual disability using photovoice. Scand J Occup Ther. 2018 Sep;25(5):371-381. doi: 10.1080/11038128.2018.1502349. Epub 2018 Oct 3.
citation: Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.
citation: Di Marino E, Tremblay S, Khetani M, Anaby D. The effect of child, family and environmental factors on the participation of young children with disabilities. Disabil Health J. 2018 Jan;11(1):36-42. doi: 10.1016/j.dhjo.2017.05.005. Epub 2017 Jun 1.
citation: Haley SM, Coster WJ, Dumas HM, Fragala-Pinkham MA, Kramer J, Ni P, Tian F, Kao YC, Moed R, Ludlow LH. Accuracy and precision of the Pediatric Evaluation of Disability Inventory computer-adaptive tests (PEDI-CAT). Dev Med Child Neurol. 2011 Dec;53(12):1100-6. doi: 10.1111/j.1469-8749.2011.04107.x. Epub 2011 Nov 11.