Clinical Trial ROBERT® - Project Active Training

Lifescience-Robotics

Status: Completed

Conditions: Spinal Cord Injuries; Apoplexy; Stroke; Usability; Safety

Treatments: Device: ROBERT®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04304976

N-20190038

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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®

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Training with ROBERT® Passive

Experimental group

Description:

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

Treatment:

Device: ROBERT®

Training with ROBERT® Active

Experimental group

Description:

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

Treatment:

Device: ROBERT®