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Completed

NCT Number: NCT04304976

Clinical Trial ROBERT® - Project Active Training

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.

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Key information

Conditions

Apoplexy; Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Safety Spinal Cord Diseases Spinal Cord Injuries Stroke Trauma, Nervous System Usability Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Hospital, Neuro Unit Nord.

Frederikshavn, North Denmark, 9900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

ROBERT®

Device

Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients.

Primary outcomes

  1. Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed

    Time frame: Up to 19 weeks

    • 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
    • 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Lifescience-Robotics

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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