Optimize Motor Learning to Improve Neurorehabilitation (OnLINE)

The objective of this study is to develop and evaluate novel robotic training strategies that modulate errors based on the subjects' individual motor and cognitive needs. For this purpose, healthy adults and neurologic patients will participate in robotic motor learning experiments. Patients have a diagnosis of a neurological disease (i.e., stroke, spinal cord injury, multiple sclerosis, Guillain-Barré syndrome) limiting arm motor function.

Study Overview

• Status: Completed
• Conditions: Stroke; Neurologic Disorder
• Intervention / Treatment: Behavioral: Robotic motor training

Detailed Description

Neurological patients (e.g., after stroke) engage in intensive and expensive neurorehabilitation therapy to regain part of their former motor functional ability to perform everyday activities with often limited and unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation therapy, providing cost-effective, high repetition and task-oriented training. However, results of an initial body of work comparing the effectiveness of robotic training strategies are highly inconclusive. A possible explanation is that most current robotic systems cover only one neurorehabilitation strategy (e.g. reducing or augmenting movement errors) and may thus insufficiently address the subjects' individual needs and the characteristics of the task to be learned. In this study, Investigators will perform several motor learning experiments with healthy adult and neurological patients in order to evaluate the relative motor and cognitive benefits of newly developed robotic training strategies that modulate errors based on the subject's age, skill level and tasks characteristics. The effects of the new strategies will be compared to classical robotic assistance, and to non-robotic feedback approaches, such as visual feedback. The culmination of this work may help to optimize training benefits of already existing rehabilitation robots.

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged ≥18 years
• Informed Consent as documented by signature ("Informed Consent" form)
• Bodyweight <120 kg
• Ability to communicate effectively with the examiner so that the validity of the patient's data could not be compromised

Exclusion Criteria:

• Excessive spasticity of the affected arm (Ashworth Scale ≥3)
• Serious medical or psychiatric disorder
• Orthopaedic, rheumatological, or other disease restricting movements of the paretic arm
• Shoulder subluxation
• Skin ulcerations at the paretic arm
• Cyber-sickness (i.e., nausea when looking at a screen or playing computer games)
• Serious cognitive defects or aphasia preventing effective use of the robotic devices
• Severe visual and auditory impairments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic motor training; Participants will perform motor tasks (i.e. movements) with upper limb robotic devices applying different strategies (e.g. supporting or challenging the subject, or being fully compliant).	Behavioral: Robotic motor training; The experiments consist in performing motor tasks with upper-limb robotic devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in kinematic performance assessed by the robot	Motion changes from baseline in the kinematic variables assessed by the robot and motion trackers during the motor learning task. The kinematic performance analysis consists of end-effector position in the x, y, and z-axis, in meters, and joint angles in degrees.	Baseline, training (immediately after baseline), retention (1-2 days after the training)
Change in kinetic performance assessed by the robot	Force changes from baseline in the kinetic variables assessed by the robot using force sensors during the motor learning task. Kinetic performance analysis consists of interaction forces in x, y, and z-axis, in N and applied robot joint torques by the motors, in Nm.	Baseline, training (immediately after baseline), retention (1-2 days after the training)
Spatial analysis of changes in evoked potentials as assessed by Electroencephalography (EEG) measurement	Electroencephalographical assessment of changes in evoked potentials i.e. the electrical activity of the brain in response to stimulation of specific sensory nerve pathways.	Baseline, training (immediately after baseline), retention (1-2 days after the training)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in embodiment	Virtual Reality (VR) Embodiment Scale, Self administered Likert scale of 1-7 (Strongly Disagree to Strongly Agree)	Before Intervention, Immediately after the end of intervention
Spatial analysis of changes in Task-Based Brain Connectivity as assessed by Electroencephalography (EEG) measurement	Changes in Task-Based Brain Connectivity from baseline in electroencephalography measurement	Baseline, training (immediately after baseline or 1-2 days after baseline), retention (1-2 days after the training)
Change in Motivation as assessed by Intrinsic Motivation Inventory (IMI)	Intrinsic Motivation Inventory, Self administered. Likert scale of 1-7 (1: not at all true - 4: somewhat true - 7: very true)	Before Intervention, Immediately after the end of intervention, at the end of the session
Change in Cognitive Load as assessed by National Aeronautics and Space Administration (NASA) (Raw) Task Load Index	Self-reported cognitive load during a task, Self-administered National Aeronautics and Space Administration (Raw) Task Load Index (TLX), analog scale mapped from 0 to 100 (Endpoints: Low/High, Good/Poor)	Immediately after the end of intervention, At the end of the session
System Usability as assessed by System Usability Scale (SUS)	Self reported system usability assessed by System Usability Scale (SUS) Likert scale of 1-5 (Strongly agree to Strongly disagree)	Immediately after the end of intervention, At the end of the session

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Laura Marchal-Crespo, Prof. Dr., University of Bern, ARTORG Center for Biomedical Engineering Research

Publications and helpful links

General Publications

• Ozen O, Buetler KA, Marchal-Crespo L. Towards functional robotic training: motor learning of dynamic tasks is enhanced by haptic rendering but hampered by arm weight support. J Neuroeng Rehabil. 2022 Feb 13;19(1):19. doi: 10.1186/s12984-022-00993-w.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Motor Learning; Neurorehabilitation; Robotic Rehabilitation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Nervous System Diseases
• Other Study ID Numbers: 2018-01179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after publications and it will stay accessible as long as the journal regulation permits.
• IPD Sharing Access Criteria: Being able to access the journal paper
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No