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Clinical Trial ROBERT® - Project Active Training

Primary Purpose

Apoplexy; Stroke, Spinal Cord Injuries, Safety

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ROBERT®
Sponsored by
Lifescience-Robotics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Apoplexy; Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®

Sites / Locations

  • Region Hospital, Neuro Unit Nord.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Training with ROBERT® Passive

Training with ROBERT® Active

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 26, 2020
Last Updated
February 18, 2021
Sponsor
Lifescience-Robotics
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1. Study Identification

Unique Protocol Identification Number
NCT04304976
Brief Title
Clinical Trial ROBERT® - Project Active Training
Official Title
Clinical Trial ROBERT® - Project Active Training
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
April 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifescience-Robotics

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apoplexy; Stroke, Spinal Cord Injuries, Safety, Usability

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training with ROBERT® Passive
Arm Type
Experimental
Arm Description
Training performed with ROBERT® in passive mode, resulting in active assistive training.
Arm Title
Training with ROBERT® Active
Arm Type
Experimental
Arm Description
Traning performed with ROBERT® in Active mode, resulting in active resistive training.
Intervention Type
Device
Intervention Name(s)
ROBERT®
Intervention Description
Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients.
Primary Outcome Measure Information:
Title
Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed
Description
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.
Time Frame
Up to 19 weeks
Title
Safety, Capture adverse events.
Description
Safety is evaluated during patient use, nr of treatment-related adverse events is recorded during training sessions.
Time Frame
Up to 19 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle Rovsing Jørgensen, Therapist
Organizational Affiliation
Neuro Unit Nord, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Hospital, Neuro Unit Nord.
City
Frederikshavn
State/Province
Nordjylland
ZIP/Postal Code
9900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
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Clinical Trial ROBERT® - Project Active Training

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