RecruitingNot ApplicableNCT07461259

Safety and Feasibility of TWIICE Rise - Phase 2

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

Sponsor

TWIICE

Enrollment

15 participants

Start Date

Jul 25, 2023

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries Gait Disorders, Neurologic

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 10 sessions in different settings (clinic, home, and community environment).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called TWIICE Rise for people with gait disorders, neurologic and spinal cord injuries. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETWIICE Rise

TWIICE Rise is a lower-limb overground robotic exoskeleton intended for patients with spinal cord injury (SCI). TWIICE Rise is intended to perform ambulatory functions in rehabilitation institutions, home, or community environment under the supervision of a specially trained coach.