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Spinal Muscular AtrophySMAPmobNCT05589987

Spinal Muscular Atrophy on Wheels, Using Power Mobility

A study testing power mobility in people with Spinal Muscular Atrophy, run by University of Castilla-La Mancha at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 months to 5 years
Conditions the study is for
Spinal Muscular Atrophy
What is being tested?
power mobility
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesSpain
Study dates
1 Oct 2022to 1 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of SMA type I
  • Ages between 10 months to 5 years.
  • No previous experience with motorized mobility.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Rocío Palomo-Carrión, PhD contact

925268800 ext. 5831

Rocio.Palomo@uclm.es

Purificación López-Muñoz, PhD contact

Purifiacion.Lopez@uclm.es

Spain2 sites, 2 recruiting
  • Rocío Castilla-La Palomo-Carrión

    Toledo, Castilla-La Mancha/Toledo, 45071

    Rocío CL Palomo-Carrión, PhD, Rocio.Palomo@uclm.es

    Purificación López-Muñoz, PhD, Purifiacion.Lopez@uclm.es

    Recruiting
  • University of Castilla-La Mancha

    Toledo, 45071

    Rocío Palomo-Carrión, PhD, 925268800 ext. 5831, Rocio.Palomo@uclm.es

    Purificación López-Muñoz, PhD, Purifiacion.Lopez@uclm.es

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Read the 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.
Being tested
power mobility
Keywords
home, family, natural environment, participation
Medical subject headings
Muscular Atrophy, Spinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • power mobilityDevice

    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.

Study groups in NCT05589987
Study groupRoleWhat they receive
Power mobilityExperimentalThe study will take place in the child's natural environment for 12 weeks.
Receives: Device: power mobility
Non-power mobilityNo interventionChildren 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. QUEST (Version 2.0) Quebec User Evaluation of Satisfaction with assistive Technology

    the scale includes 12 items rated on a 5-point satisfaction scale. approximately 10-15 minutes are require to complete the evaluation.

    Measured: baseline and Change from basaline at week 12

  2. YC-PEM (Young Children's Participation & Environment Measure)

    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

    Measured: baseline, Change from basaline at week 12 and Change from basaline at week 16

  3. Pediatric Evaluation of Disability Inventory-Computer Adaptive-test (PEDI-CAT)

    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.

    Measured: baseline, Change from basaline at week 12 and Change from basaline at week 16

  4. Photovoice

    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

    Measured: baseline,Change from basaline at week 12

Secondary outcomes (3)
  1. Goal Attainment Scaling (GAS)

    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)

    Measured: baseline, Change from basaline at week 12

  2. Switch Activation

    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

    Measured: at the end of week 4, 8, and week 12

  3. Daily driving journal

    Parents will record the date, duration (minutes) location, and activities during each driving session in a daily driving journal.

    Measured: baseline, week 12 and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start1 Oct 2022
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion1 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 groups: experimental and control groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05589987
Sponsor's protocol ID
Rpalomo03
Acronym
SMAPmob
Status last verified
Oct 2022
First submitted
10 Oct 2022
Last updated
21 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: we will share the data when researchers ask us about that

Publications

  • 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.

    PubMed 25346245
  • 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.

    PubMed 24764156
  • 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.

    PubMed 26340446
  • 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.

    PubMed 16096237
  • 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.

    PubMed 11508406
  • 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.

    PubMed 30280952
  • 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.

    PubMed 23562111
  • 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.

    PubMed 28624289
  • 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.

    PubMed 22077695
  • Diaz-Lopez CI, Palomo-Carrion R, Coello-Villalon M, Romay-Barrero H, Plasencia-Robledo M, Lopez-Munoz P. Relationships between home and community participation, social-cognitive skills, and powered mobility learning in children with SMA type I: A randomized, waiting-list controlled trial. Assist Technol. 2026 Sep;38(5):402-412. doi: 10.1080/10400435.2026.2628660. Epub 2026 Feb 17.

    PubMed 41701870
  • Diaz-Lopez CI, Palomo-Carrion R, Coello-Villalon M, Rodenas-Martinez M, Pacheco-da-Costa S, Romay-Barrero H, Lopez-Munoz P. The impact of early powered mobility training in families and children with Spinal Muscular Atrophy Type I. Assist Technol. 2026 Sep;38(5):391-401. doi: 10.1080/10400435.2025.2546856. Epub 2025 Aug 22.

    PubMed 40844591

Questions about this trial

What is this clinical trial studying?

A study testing power mobility in people with Spinal Muscular Atrophy, run by University of Castilla-La Mancha at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rocío Palomo-Carrión, PhD (925268800 ext. 5831, Rocio.Palomo@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QUEST (Version 2.0) Quebec User Evaluation of Satisfaction with assistive Technology (time frame: baseline and Change from basaline at week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05589987, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.

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