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

NCT ID: NCT03974750

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2030-12-31

Brief Summary

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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).

Detailed Description

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Over 3 consecutive days, healthy individuals and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabilitation robot REAplan(R).

They will practice several tasks on the robot REAplan (R) (bimanual version), requiring either movements with the affected arm (unimanual tasks) and complex, coordinated movements with both arms (bimanual tasks).

In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...).

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Evaluation of bimanual motor skill learning Motor skill learning with a rehabilitation robot
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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intervention

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

control intervention

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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


\- 18-90 years

Exclusion Criteria

* 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 :


* neurological conditions interfering with the study
* drug/alcohol abuse
* pyschiatric condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role collaborator

University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

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Pr Yves Vandermeeren, MD, PhD

MD, PhD, Neurologist, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yves Y Vandermeeren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Yvoir, Namur, Belgium

Site Status RECRUITING

Department of Neurology, CHU Mont-Godinne

Yvoir, Namur, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Yves Vandermeeren, MD, PhD

Role: CONTACT

+3281423321

Facility Contacts

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Yves Vandermeeren, MD, PhD

Role: primary

+32 81 42 3321

Yves Vandermeeren, MD,PhD

Role: primary

081 42 3321 ext. +32

References

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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.

Reference Type BACKGROUND
PMID: 29326573 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31088342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29420360 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35300709 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33433485 (View on PubMed)

Other Identifiers

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bimMsKL

Identifier Type: -

Identifier Source: org_study_id

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