NCT05589987

Spinal Muscular Atrophy on Wheels, Using Power Mobility

Community's Participation of Children With Spinal Muscular Atrophy Using Power Mobility

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 10 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Muscular Atrophy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-11-30
• Completion: 2024-02-01
• First posted: 2022-10-21
• Last updated: 2022-10-21

Locations

2 sites across 1 country: Spain