Clinical Trial ROBERT® - Project Active Training

February 18, 2021 updated by: Lifescience-Robotics
The overall purpose with this clinical trial is to, monitor and secure ROBERT®'s clinical performance and safety in a clinical environment in the regional hospital North Denmark, Neuro Unit North. The purpose of the study is to investigate if ROBERT® has the ability to 1. Perform guided active training. 2. Perform resistance based active training. And validate the safety of ROBERT® in a clinical environment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Nordjylland
      • Frederikshavn, Nordjylland, Denmark, 9900
        • Region Hospital, Neuro Unit Nord.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalised patients at Neuro Unit North, during the trial period.
  • 18 years or older.
  • Can read, understand and speak Danish
  • Reduced motor function in lower extremities.

Exclusion Criteria:

  • No able to sign informed consent.
  • Cannot read, understand or speak Danish
  • Patients with unstable fractures in columna, pelvis or lower extremities.
  • Patients with the risk of ulcers, or with exceedingly sensitive skin.
  • The patient is refusing to train with ROBERT®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training with ROBERT® Passive
Training performed with ROBERT® in passive mode, resulting in active assistive training.
Device: ROBERT®
Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients.
Experimental: Training with ROBERT® Active
Traning performed with ROBERT® in Active mode, resulting in active resistive training.
Device: ROBERT®
Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed
Time Frame: Up to 19 weeks
  1. Active training capabilities will be assessed, 3 active motions are planned (the therapist has to be active) by the therapist, and manually performed by hand. The resistance perceived by the therapist is then compared to the expert opinion of the therapist to evaluate if this correlates with, small, medium, and large resistance. This is evaluated as passed/not passed for all 3 motions
  2. Active assistive training capabilities will be assessed: 3 passive motions are planned (the robot moves, the therapist follows movement), by the therapist and the robot starts performing the motions, the therapist performs a small, moderate and large assistive movement in conjunction with the robot. The results in % of activity in the path of motion are displayed, and the therapist evaluates if this is in agreement with what they would categorise as a small, moderate and large assistive movement respectively. This is evaluated as passed/not passed for all 3 motions.
Up to 19 weeks
Safety, Capture adverse events.
Time Frame: Up to 19 weeks
Safety is evaluated during patient use, nr of treatment-related adverse events is recorded during training sessions.
Up to 19 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifescience-Robotics

Investigators

  • Principal Investigator: Helle Rovsing Jørgensen, Therapist, Neuro Unit Nord, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2019

Primary Completion (Actual)

January 16, 2020

Study Completion (Actual)

April 21, 2020

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20190038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on ROBERT®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe