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

October 18, 2022 updated by: University of Castilla-La Mancha

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Toledo, Spain, 45071
    • Castilla-La Mancha/Toledo
      • Toledo, Castilla-La Mancha/Toledo, Spain, 45071
        • Recruiting
        • Rocío Castilla-La Palomo-Carrión
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rocío Palomo-Carrión, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Power mobility
The study will take place in the child's natural environment for 12 weeks.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QUEST (Version 2.0) Quebec User Evaluation of Satisfaction with assistive Technology
Time Frame: 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.
baseline and Change from basaline at week 12
YC-PEM (Young Children's Participation & Environment Measure)
Time Frame: 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
baseline, Change from basaline at week 12 and Change from basaline at week 16
Pediatric Evaluation of Disability Inventory-Computer Adaptive-test (PEDI-CAT)
Time Frame: 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.
baseline, Change from basaline at week 12 and Change from basaline at week 16
Photovoice
Time Frame: 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
baseline,Change from basaline at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goal Attainment Scaling (GAS)
Time Frame: 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)
baseline, Change from basaline at week 12
Switch Activation
Time Frame: 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
at the end of week 4, 8, and week 12
Daily driving journal
Time Frame: 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.
baseline, week 12 and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rpalomo03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

we will share the data when researchers ask us about that

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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