Clinical Trial ROBERT® - Project Active Training

NCT04304976 | Completed

• 1 other identifier: N-20190038
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apoplexy; Stroke; Spinal Cord Injuries; Safety; Usability

Outcome Measures

Primary Outcomes (2)

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

  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.

  Safety is evaluated during patient use, nr of treatment-related adverse events is recorded during training sessions.

  Up to 19 weeks

Study Arms (2)

Training with ROBERT® Passive

EXPERIMENTAL

Training performed with ROBERT® in passive mode, resulting in active assistive training.

Device: ROBERT®

Training with ROBERT® Active

EXPERIMENTAL

Traning performed with ROBERT® in Active mode, resulting in active resistive training.

Device: ROBERT®

Interventions

ROBERT® DEVICE

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

Training with ROBERT® Active; Training with ROBERT® Passive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Lifescience-Robotics: lead

Study Sites (1)

Region Hospital, Neuro Unit Nord.

Frederikshavn, North Denmark, 9900, Denmark

Location

Related Publications (15)

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• "Ét sikkert og sammenhaengende sundhedsnetvaerk for alle."

  BACKGROUND

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  PMID: 19608100 BACKGROUND

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Helle Rovsing Jørgensen, Therapist

  Neuro Unit Nord, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 12, 2020
• Study Start: November 27, 2019
• Primary Completion: January 16, 2020
• Study Completion: April 21, 2020
• Last Updated: February 21, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)