Spinal Muscular Atrophy on Wheels, Using Power Mobility
NCT ID: NCT05589987
Last Updated: 2022-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-10-01
2024-02-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Power mobility
The study will take place in the child's natural environment for 12 weeks.
power mobility
Sessions of adjustment, adaptation and choice of the device for training will be carried out. Once the cars are fully adapted and conditioned to the environment and needs of the family and the child, the intervention will begin.
The study will take place in the child's natural environment for 12 weeks. Three 40-minute sessions per week will be held, each session includes: 1) configuration of the environment (families will be instructed by the therapists to adapt the environment to the child's situation and their conditions for driving the car): 5 min ; 2) natural play as a warm-up activity: 5 min; and 3) mobility and social training with cars: 30 min. The 30-minute driving session will involve participants learning cause and effect concepts by driving the toy car (press the button to move and release to stop). The therapist and caregivers will use verbal cues to encourage children to drive and explore the environment. All sessions will be video and audio recorded.
Non-power mobility
Children will perform their typical daily routine without any modification. After the study they will be invited to participate in the experimental group if positive benefits are obtained.
No interventions assigned to this group
Interventions
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power mobility
Sessions of adjustment, adaptation and choice of the device for training will be carried out. Once the cars are fully adapted and conditioned to the environment and needs of the family and the child, the intervention will begin.
The study will take place in the child's natural environment for 12 weeks. Three 40-minute sessions per week will be held, each session includes: 1) configuration of the environment (families will be instructed by the therapists to adapt the environment to the child's situation and their conditions for driving the car): 5 min ; 2) natural play as a warm-up activity: 5 min; and 3) mobility and social training with cars: 30 min. The 30-minute driving session will involve participants learning cause and effect concepts by driving the toy car (press the button to move and release to stop). The therapist and caregivers will use verbal cues to encourage children to drive and explore the environment. All sessions will be video and audio recorded.
Eligibility Criteria
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Inclusion Criteria
* Ages between 10 months to 5 years.
* No previous experience with motorized mobility.
Exclusion Criteria
* 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.
10 Months
5 Years
ALL
No
Sponsors
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University of Castilla-La Mancha
OTHER
Responsible Party
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Locations
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Rocío Castilla-La Palomo-Carrión
Toledo, Castilla-La Mancha/Toledo, Spain
University of Castilla-La Mancha
Toledo, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Rpalomo03
Identifier Type: -
Identifier Source: org_study_id
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