Spinal Muscular Atrophy on Wheels, Using Power Mobility (SMAPmob)

University of Castilla-La Mancha

Status: Enrolling

Conditions: Spinal Muscular Atrophy

Treatments: Device: power mobility

Study type: Interventional

Funder types: Other

Identifiers

NCT05589987

Rpalomo03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 10 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Power mobility

Experimental group

Description:

The study will take place in the child's natural environment for 12 weeks.

Treatment:

Device: power mobility

Non-power mobility

No Intervention group

Description:

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.