MedTrace Logo

Safety and Feasibility of TWIICE Rise

NCT05926310 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-08-08

No results posted yet for this study

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).

Conditions

  • Spinal Cord Injuries
  • Gait Disorders, Neurologic

Interventions

DEVICE

TWIICE 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.

Sponsors & Collaborators

  • Swiss Paraplegic Research, Nottwil

    collaborator NETWORK

  • TWIICE

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2024-04-30
Completion
2024-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926310 on ClinicalTrials.gov