Spinal Muscular Atrophy
Conditions
Keywords
home, family, natural environment, participation
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.
Interventions
DEVICEpower 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.
Sponsors
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the masking will be of the evaluator. The assessments will be passed by a study evaluator and scored by an evaluator external to the study to ensure blinding of the groups.
Intervention model description
2 groups: experimental and control groups.
Eligibility
Sex/Gender
ALL
Age
10 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QUEST (Version 2.0) Quebec User Evaluation of Satisfaction with assistive Technology | baseline and Change from basaline at week 12 | the scale includes 12 items rated on a 5-point satisfaction scale. approximately 10-15 minutes are require to complete the evaluation. |
| YC-PEM (Young Children's Participation & Environment Measure) | baseline, Change from basaline at week 12 and Change from basaline at week 16 | to be used for children from zero to five years, explores the frequency of participation in activities. Parents will report their child's participation across home, community and childcare |
| Pediatric Evaluation of Disability Inventory-Computer Adaptive-test (PEDI-CAT) | baseline, Change from basaline at week 12 and Change from basaline at week 16 | It is answered by the children's caregiver and has an item bank divided into two domains: (1) mobility, which includes 75 items ranging from basic motor skills (e.g., sitting without support) to more difficult motor skills (e.g., running or climbing a step ladder). Additionally, this domain includes the use of walking devices; (2) cognitive/social, which includes 60 items related to interaction (e.g., follows the gaze of another person), communication (e.g., uses gestures to ask for something), everyday cognition (e.g., recognizes his/her name), and self-management (e.g., when upset response without hitting). In these domains, the four-point scores (unable, hard, a little hard, easy) are based on different levels of difficulty. The overall score is transformed in a normative score (based on age) and a continuous score that will be used in the analyses. |
| Photovoice | baseline,Change from basaline at week 12 | to record and present everyday realities using photography; promote dialogue and critical reflection of reality and know the strengths and weaknesses of the target audience; and reach decision makers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Switch Activation | at the end of week 4, 8, and week 12 | Switch activation is defined as when the switch is pressed to activate the modified ride-on car and make it go, thereby moving in space from one place to another |
| Daily driving journal | baseline, week 12 and week 16 | Parents will record the date, duration (minutes) location, and activities during each driving session in a daily driving journal. |
| Goal Attainment Scaling (GAS) | baseline, Change from basaline at week 12 | GAS is an objective method of quantifying goal attainment. Goals are scored on a Likert-type scale from -2 (representing no positive change at all from baseline/ regression), -1 (a little less change than expected), 0 (attainment of goal at the expected level), +1 (a little more change than expected), to +2 (attainment of goal at much more than the expected level) |
Countries
Spain
Contacts
Primary ContactRocío Palomo-Carrión, PhD
Backup ContactPurificación López-Muñoz, PhD
Outcome results
None listed