Optimize Motor Learning to Improve Neurorehabilitation

NCT04759976 | Completed DMC

• 1 other identifier: 2018-01179
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Neurologic Disorder

Keywords

Neurorehabilitation; Robotic Rehabilitation; Motor Learning

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in embodiment

  Before Intervention, Immediately after the end of intervention

• Spatial analysis of changes in Task-Based Brain Connectivity as assessed by Electroencephalography (EEG) 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)

  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

  Immediately after the end of intervention, At the end of the session

• System Usability as assessed by System Usability Scale (SUS)

  Immediately after the end of intervention, At the end of the session

Study Arms (1)

Robotic motor training

EXPERIMENTAL

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

Interventions

Robotic motor training BEHAVIORAL

The experiments consist in performing motor tasks with upper-limb robotic devices.

Robotic motor training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35152897 DERIVED

MeSH Terms

Conditions

Stroke; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Laura Marchal-Crespo, Prof. Dr.

  University of Bern, ARTORG Center for Biomedical Engineering Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 18, 2021
• Study Start: January 25, 2019
• Primary Completion: April 15, 2024
• Study Completion: October 16, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be available after publications and it will stay accessible as long as the journal regulation permits.
• Access Criteria: Being able to access the journal paper

Locations

CH (1)