Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy

NCT05416034 | Completed

• 1 other identifier: KINDER
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of the use of a pediatric exoskeleton on the quality of life of children, specifically in the psychological and care dimensions. Other objectives are to evaluate changes at the physical and functional level.

Conditions

Spinal Muscular Atrophy Type II

Keywords

exoskeleton; spinal muscular atrophy; care; quality of life; robotics

Outcome Measures

Primary Outcomes (3)

• Phenomenological Interviews

  Assess the psychological impact of the experience on both children and the main care giver through phenomenological interviews. The phenomenological interview was an open interview evaluating how the participants lived the experience of using an exoskeleton at home

  2 months

• Care impact

  To evaluate the impact of the experience in self-care of children by conducting nursing evaluations based on the Self-Care Theory developed by Dorothea Orem, before, during the use of the exoskeleton and at the end. To collect the data needed to complete the nursing assessment, structured nursing interviews were conducted with each child's primary caregiver. No scales are used to assess the care impact. A positive care impact will be considered if by using the exoskeleton any children or parents have an increase in any self-care agency. A negative care impact will be considered if by using the exoskeleton any self-care demand can not be satisfied by the self-care agency of any of the children or parents.

  2 months

• Participant observation

  Assess the psychological impact of the experience on both children and the main care giver through participant observation. Participant observation was performed during exoskeleton use sessions in the children's homes. Data was taken by field notes of everything that happened during the session.

  2 months

Secondary Outcomes (14)

• Upper limb Function

  2 months

• Number of Steps

  2 months

• Muscle Strength

  2 months

• Number of participants with abnormal vital signs

  2 months

• Respiratory rate (breaths/min)

  2 months

Study Arms (1)

Use of the ATLAS 2030 exoskeleton at home

EXPERIMENTAL

Children with Spinal Muscular Atrophy Type II will received robot assisted gait therapy with the ATLAS 2030 exoskeleton at their homes 5 days a week during two months in 60 minutes sessions

Device: Use of the ATLAS 2025 exoskeleton at home

Interventions

Use of the ATLAS 2025 exoskeleton at home DEVICE

Each participant will use the ATLAS 2025 exoskeleton at their homes, 5 days a week during a period of two months, for walking with the device and performing motor activities in 60 minutes duration sessions..

Use of the ATLAS 2030 exoskeleton at home

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients between 4 and 9 years old
• Patients with a confirmed diagnostic of Spinal Muscular Atrophy Type II

You may not qualify if:

• Weight over 40 Kg
• Hip-knee distance less than 22 cm or greater than 38cm
• Knee-ankle distance less than 21 cm or greater than 37cm
• Distance between trochanters less than 24 cm or greater than 40cm
• Joint range limit greater than 20º

Sponsors & Collaborators

• MarsiBionics: lead
• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: collaborator

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Spinal Muscular Atrophies of Childhood; Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: June 13, 2022
• Study Start: December 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: August 31, 2018
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)