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

NCT ID: NCT04642599

Last Updated: 2024-12-16

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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

They will practice several tasks on the robot REAplan® (bimanual version), requiring either movements with the affected arm (unimanual tasks) or 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, ...).

Hand/digits motor function will be also evaluated with the kinetic device DexTrain®.

Conditions

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Chronic Cerebellar Stroke Healthy Individuals (Controls)

Keywords

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Stroke Cerebellar Disorders Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Cerebellar Stroke Cerebellar Hemorrhage Cerebellar Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Evaluation of bimanual motor skill learning
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Chronic Cerebellar Stroke

Participants with a chronic cerebellar stroke

Group Type EXPERIMENTAL

Bimanual motor skill learning with the REAplan® rehabilitation robot

Intervention Type DEVICE

REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements

Healthy Individuals (Controls)

healthy participants

Group Type ACTIVE_COMPARATOR

Bimanual motor skill learning with the REAplan® rehabilitation robot

Intervention Type DEVICE

REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements

Interventions

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Bimanual motor skill learning with the REAplan® rehabilitation robot

REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* having a chronic cerebellar stroke (\>6 months)
* aged 18-90 years
* with a demonstrated stroke (ischemic or hemorrhagic) 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

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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Fonds National de la Recherche Scientifique

OTHER

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role collaborator

Louvain Bionics, UCLouvain

UNKNOWN

Sponsor Role collaborator

University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

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Pr Yves Vandermeeren, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yves Vandermeeren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Mont-Godinne

Locations

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

Yvoir, Namur, Belgium

Site Status

Countries

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Belgium

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)

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)

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)

Gathy E, Cadiat N, Gerardin E, Lambert J, Herman B, Leeuwerck M, Bihin B, Vandermeeren Y. Bimanual coordinated motor skill learning in patients with a chronic cerebellar stroke. Exp Brain Res. 2024 Jun;242(6):1517-1531. doi: 10.1007/s00221-024-06830-x. Epub 2024 May 9.

Reference Type DERIVED
PMID: 38722346 (View on PubMed)

Other Identifiers

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BimMSkL-Cerebellum

Identifier Type: -

Identifier Source: org_study_id