Spinal Muscular Atrophy on Wheels, Using Power Mobility

NCT05589987 | Unknown

• 1 other identifier: Rpalomo03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Muscular Atrophy

Keywords

home; family; natural environment; participation

Outcome Measures

Primary Outcomes (4)

• 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.

  baseline and Change from basaline at week 12

• 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

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

• 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.

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

• 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

  baseline,Change from basaline at week 12

Secondary Outcomes (3)

• Goal Attainment Scaling (GAS)

  baseline, Change from basaline at week 12

• Switch Activation

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

• Daily driving journal

  baseline, week 12 and week 16

Study Arms (2)

Power mobility

EXPERIMENTAL

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

Device: power mobility

Non-power mobility

NO INTERVENTION

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.

Interventions

power mobility DEVICE

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.

Power mobility

Eligibility Criteria

• Age: 10 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (2)

Rocío Castilla-La Palomo-Carrión

Toledo, Castilla-La Mancha/Toledo, 45071, Spain

RECRUITING

University of Castilla-La Mancha

Toledo, 45071, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 25346245 RESULT

• 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.

  PMID: 24764156 RESULT

• 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.

  PMID: 26340446 RESULT

• 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.

  PMID: 16096237 RESULT

• 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.

  PMID: 11508406 RESULT

• 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.

  PMID: 30280952 RESULT

• 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.

  PMID: 23562111 RESULT

• 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.

  PMID: 28624289 RESULT

• 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.

  PMID: 22077695 RESULT

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Central Study Contacts

Rocío Palomo-Carrión, PhD

CONTACT

925268800; Rocio.Palomo@uclm.es

Purificación López-Muñoz, PhD

CONTACT

Purifiacion.Lopez@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups: experimental and control groups.

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 21, 2022
• Study Start: October 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: February 1, 2024
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

ES (2)