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Safety and Feasibility of TWIICE Rise

Spinal Cord Injuries Clinical Trial

Official title:
Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury

Clinical Trial Summary

The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury. This study is done in two phases: The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with 5 patients over 6 sessions in clinic. The second phase is being conducted with TWIICE Rise 1.0. This version has potentially improved functionalities based on feedback from Phase 1. Safety and feasibility will be assessed with 10 patients over 24 sessions in different settings (clinic, home, and community environment).

Clinical Trial Description

The aim of this clinical trial is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton assisted ambulation in patients with a spinal cord injury. The study is thus done in two phases. The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with five patients over 6 sessions in clinic. This phase allows the manufacturer to collect data that can be used to improve the device design if necessary. The second phase of the study is being conducted with TWIICE Rise 1.0. Safety and feasibility will be assessed with 10 patients over 24 sessions in different settings (clinic, home, and community environment) to test the device intended use. The first sessions are done at the rehabilitation specialized center to benefit from the clinical settings to learn to walk with the exoskeleton. Once the patients reach sufficient ambulatory skills determined by a score of 29 in the Mobility SkillsTests, the following sessions can be done at home and community settings. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05926310
Study type Interventional
Source TWIICE
Contact Mario Widmer, PhD
Phone +41 41 939 51 97
Email mario.widmer@paraplegie.ch
Status Recruiting
Phase N/A
Start date July 25, 2023
Completion date June 2024
View Details
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