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

Marsi Bionics

Status: Completed

Conditions: Spinal Muscular Atrophy Type II

Treatments: Device: Use of the ATLAS 2025 exoskeleton at home

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05416034

KINDER

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Use of the ATLAS 2030 exoskeleton at home

Experimental group

Description:

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

Treatment:

Device: Use of the ATLAS 2025 exoskeleton at home