Clinical Trial ROBERT® - Project Active Training

Not Applicable

Completed

• Conditions: Safety; Usability; Apoplexy; Stroke; Spinal Cord Injuries
• Interventions: Device: ROBERT®

• Registration Number: NCT04304976
• Lead Sponsor: Lifescience-Robotics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-27
• Primary Completion: 2020-01-16
• Study First Submitted: 2020-02-26
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-12
• Study Completion: 2020-04-21
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training with ROBERT® Active	ROBERT®	Traning performed with ROBERT® in Active mode, resulting in active resistive training.
Training with ROBERT® Passive	ROBERT®	Training performed with ROBERT® in passive mode, resulting in active assistive training.

Primary Outcome Measures

Name	Time	Method
Safety, Capture adverse events.	Up to 19 weeks	Safety is evaluated during patient use, nr of treatment-related adverse events is recorded during training sessions.
Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed	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.

Trial Locations

Locations (1)

Region Hospital, Neuro Unit Nord.; 🇩🇰 Frederikshavn, Nordjylland, Denmark