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

NCT ID: NCT05416034

Last Updated: 2022-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Muscular Atrophy Type II

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Use of the ATLAS 2030 exoskeleton at home

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

Group Type EXPERIMENTAL

Use of the ATLAS 2025 exoskeleton at home

Intervention Type 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..

Interventions

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Use of the ATLAS 2025 exoskeleton at home

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..

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role collaborator

MarsiBionics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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KINDER

Identifier Type: -

Identifier Source: org_study_id

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