Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals

NCT03974750 | Recruiting

• 1 other identifier: bimMsKL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

To test the capacity of healthy and chronic stroke patients to learn and retain a complex bimanual motor skill, trained on the neurorehabilitation robot REAplan (R) (bimanual version).

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot

  bimanual Speed/Accurady Trade-off: mathematical computation of the relationship bewteen speed and accuracy

  change between baseline (Day 1) and after training (Day 3)

• bi-CO, bimanual Coordination factor measured by the REAplan robot

  bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms

  change between baseline (Day 1) and after training (Day 3)

• bi-Force, bimanual Coordination factor measured by the REAplan robot

  bimanual forces, forces exerted in the wrong direction by each arm (Newtons)

  change between baseline (Day 1) and after training (Day 3)

Secondary Outcomes (8)

• bi-SAT on bimanual REACHING (REAplan robot)

  change between baseline (Day 1) and after training (Day 3)

• bi-Force on bimanual REACHING (REAplan robot)

  change between baseline (Day 1) and after training (Day 3)

• bi-CO on bimanual REACHING (REAplan robot)

  change between baseline (Day 1) and after training (Day 3)

• bi-smoothness on bimanual REACHING (REAplan robot)

  change between baseline (Day 1) and after training (Day 3)

• bi-error on bimanual REACHING (REAplan robot)

  change between baseline (Day 1) and after training (Day 3)

Study Arms (2)

intervention

EXPERIMENTAL

Training on the rehabilitation robot REAplan(R) to learn complex, coordinated bimanual movements

Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot

control intervention

ACTIVE COMPARATOR

Training on the rehabilitation robot REAplan(R) with simple movements

Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot

Interventions

Bimanual motor skill learning with the REAplan(R) rehabilitation robot DEVICE

REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements

control intervention; intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having a chronic stroke (\>6 months)
• aged 18-90 years
• with demonstrate a stroke lesion on brain imaging.

You may not qualify if:

• difficulty in understanding or executing commands
• drug/alcohol abuse
• severe aphasia / cognitive deficits interfering with study
• inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)
• multiple strokes / dementia / psychiatric condition
• botulinum toxin injections (to be evaluated)
• HEALTHY INDIVIDUALS :
• \- 18-90 years
• neurological conditions interfering with the study
• drug/alcohol abuse
• pyschiatric condition

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead
• Université Catholique de Louvain: collaborator

Study Sites (2)

CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit

Yvoir, Namur, 5530, Belgium

RECRUITING

Department of Neurology, CHU Mont-Godinne

Yvoir, Namur, Belgium

RECRUITING

Related Publications (5)

• Yeganeh Doost M, Orban de Xivry JJ, Bihin B, Vandermeeren Y. Two Processes in Early Bimanual Motor Skill Learning. Front Hum Neurosci. 2017 Dec 20;11:618. doi: 10.3389/fnhum.2017.00618. eCollection 2017.

  PMID: 29326573 BACKGROUND

• Doost MY, Orban de Xivry JJ, Herman B, Vanthournhout L, Riga A, Bihin B, Jamart J, Laloux P, Raymackers JM, Vandermeeren Y. Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Jun;33(6):486-498. doi: 10.1177/1545968319847963. Epub 2019 May 15.

  PMID: 31088342 BACKGROUND

• Dehem S, Gilliaux M, Lejeune T, Delaunois E, Mbonda P, Vandermeeren Y, Detrembleur C, Stoquart G. Effectiveness of a single session of dual-transcranial direct current stimulation in combination with upper limb robotic-assisted rehabilitation in chronic stroke patients: a randomized, double-blind, cross-over study. Int J Rehabil Res. 2018 Jun;41(2):138-145. doi: 10.1097/MRR.0000000000000274.

  PMID: 29420360 BACKGROUND

• Gerardin E, Bontemps D, Babuin NT, Herman B, Denis A, Bihin B, Regnier M, Leeuwerck M, Deltombe T, Riga A, Vandermeeren Y. Bimanual motor skill learning with robotics in chronic stroke: comparison between minimally impaired and moderately impaired patients, and healthy individuals. J Neuroeng Rehabil. 2022 Mar 17;19(1):28. doi: 10.1186/s12984-022-01009-3.

  PMID: 35300709 DERIVED

• Yeganeh Doost M, Herman B, Denis A, Sapin J, Galinski D, Riga A, Laloux P, Bihin B, Vandermeeren Y. Bimanual motor skill learning and robotic assistance for chronic hemiparetic stroke: a randomized controlled trial. Neural Regen Res. 2021 Aug;16(8):1566-1573. doi: 10.4103/1673-5374.301030.

  PMID: 33433485 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Yves Y Vandermeeren, MD, PhD

  Université catholique de Louvain, Institute of NeuroScience (IONS) NEUR / CHU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Vandermeeren, MD, PhD

CONTACT

+3281423321; yves.vandermeeren@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Neurologist, Principal Investigator, Clinical Professor

Model Details: Evaluation of bimanual motor skill learning Motor skill learning with a rehabilitation robot

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 5, 2019
• Study Start: July 1, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Up to 2 years after publication of the scientific articles
• Access Criteria: none (public)

Locations

BE (2)