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Myosuit Chronic Stroke Protocol

NCT05579197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-20

No results posted yet for this study

Summary

A stroke is a vascular condition that can suddenly cause the loss of neurological functions. The disability derived from a stroke can imply reduced communication and limited activities of daily living in the long term.

Thus, specifically walking rehabilitation is crucial in order to restore the lower limbs' function and to re-establish the social participation of patients.

Robotics has been demonstrated in being a suitable and effective tool in order to assist and treat post-stroke patients, thanks to its capability to deliver intensive and task-oriented training. Specifically, the exosuits, are a sub-group of robotics devices designed in lighter materials that assist the patients by actively moving the hip, knee or ankle.

Given this framework, the aim of this work is to conduct a pilot study on the usability and perceived effectiveness of a lower-limb exosuit, the Myosuit device, on post-stroke patients. The secondary aims of the study concern the evaluation of the functional performances of the patients both with and without the device and before and after the treatment.

Conditions

Interventions

DEVICE

Lower-limb robotic intervention

The intervention proposed in this study involves the use of an exosuit for lower limbs, the Myosuit. The selection of the tasks has been done in order to replicate typical activities of daily living in a structured environment, i.e. a rehabilitation hospital. Specifically, the tasks involve walking, sit to stand, balance and stair climbing. During the phases of assessment (session 2 and session 10), other devices are be used. Specifically: * The Optogait system; for a markerless gait analysis; * The Gyko sensor; an inertial sensor that will be used at the beginning of the training for the synchronisation of the signals recorded by the Myosuit and the signal recorded by the Optogait. Finally, during all the sessions, the Polar heart rate sensor is used to constantly monitor the cardiac frequency of the patients.

Sponsors & Collaborators

  • MyoSwiss AG

    collaborator UNKNOWN

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2023-04-07
Completion
2023-10-10

Countries

  • Italy

Study Locations

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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 NCT05579197 on ClinicalTrials.gov