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Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).

NCT04187209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-09-26

No results posted yet for this study

Summary

The SPIRIT study is interventional, national, prospective, open, multicentric each patient being his/her own control.

It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting a non-traumatic acute-subacute hemiplegia. The primary endpoint is defined by the patient's ability to perform the 10 MWT with the Atalante system.

The study will include at least 12 patients and takes place in three french rehabilitation centers.

Conditions

  • Stroke
  • Stroke, Acute
  • Stroke, Subacute
  • Robotics

Interventions

DEVICE

Use of the Atalante exoskeleton

A session includes a stand-up, walks over a distance of 10 meters, exercises with or without the assistance of the exoskeleton, U-turns and a sitting.

Sponsors & Collaborators

  • Wandercraft

    lead INDUSTRY

Principal Investigators

  • Jacques Kerdraon, Dr · Centre mutualiste de Rééducation et de Réadaptation de Kerpape

  • Jean-Gabriel Prévinaire, Dr · Centre Jacques Calvé - Fondation Hopale de Berck-sur-Mer

  • Soultana Tatsidou, Dr · Centre de Médecine Physique et de Réadaptation de Pionsat

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2021-01-13
Completion
2021-01-13

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT04187209 on ClinicalTrials.gov