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Chronic Cerebellar StrokeNCT04642599

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

A study testing Bimanual motor skill learning with the REAplan® rehabilitation robot in people with Chronic Cerebellar Stroke and Healthy Individuals (Controls), run by University Hospital of Mont-Godinne at 1 site in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
What is being tested?
Bimanual motor skill learning with the REAplan® rehabilitation robot
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBelgium
Study dates
29 Jan 2021to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 9Show fewer
  • neurological conditions interfering with the study
  • drug/alcohol abuse
  • pyschiatric condition

Trial locations and contacts

1 site in 1 country.

Belgium1 site

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

    Yvoir, Namur, 5530

Other trials in Belgium

About this study

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).

Read the detailed description

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®.

Being tested
Bimanual motor skill learning with the REAplan® rehabilitation robot
Keywords
Stroke, Cerebellar Disorders, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Cerebellar Stroke, Cerebellar Hemorrhage, Cerebellar Infarction
Medical subject headings
Stroke, Cerebellar Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bimanual motor skill learning with the REAplan® rehabilitation robotDevice

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

Study groups in NCT04642599
Study groupRoleWhat they receive
Chronic Cerebellar StrokeExperimentalParticipants with a chronic cerebellar stroke
Receives: Device: Bimanual motor skill learning with the REAplan® rehabilitation robot
Healthy Individuals (Controls)Active comparatorhealthy participants
Receives: Device: Bimanual motor skill learning with the REAplan® rehabilitation robot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in bi-SAT

    Bimanual Speed/Accuracy Trade-off measured by the REAplan robot bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship bewteen speed and accuracy

    Measured: Change between day 1 to 3

  2. Change in bi-CO

    Bimanual Coordination factor measured by the REAplan robot bimanual Coordination factor : mathematical measure of the phase coherence between velocities of both arms

    Measured: Change between day 1 to 3

Secondary outcomes (15)

  1. bi-SAT

    On bimanual REACHING (REAplan robot) bimanual Speed/Accurady Trade-off: mathematical computation of the relationship

    Measured: Day 1 + day 3

  2. bi-CO

    On bimanual REACHING (REAplan robot) bimanual Coordination factor: mathematical measure of the phase coherence between velocities of both arms

    Measured: Day 1 + day 3

  3. change in bi-Force

    Bimanual forces : forces exerted in the wrong direction by each arm (Newtons)

    Measured: Change between day 1 to 3

  4. bi-Force

    On bimanual REACHING (REAplan robot)

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

    Measured: Day 1 + day 3

  5. bi-smoothness

    On bimanual REACHING (REAplan robot) Smoothness of movement : Spectral Arc Length (SPARC)

    Measured: Day 1+ day 3

  6. bi-error

    on bimanual REACHING (REAplan robot) Error in centimeters or degrees during bimanual reaching

    Measured: Day 1 + day 3

  7. Dextrain

    Kinetic device measuring the movements of each finger: error and co-activation (percentage)

    Measured: Day 1 + day 3

  8. Dextrain

    Kinetic device measuring the movements of each finger: speed (milliseconds)

    Measured: Day 1 + day 3

  9. Dextrain

    Kinetic device measuring the movements of each finger: force (Newton)

    Measured: Day 1 + day 3

  10. BBT

    Box \& Blocks Test (timed transfert of blocks from one space to the other)

    Measured: Day 1 + day 3

  11. Modified International Cooperative Ataxia Rating Scale (MICARS)

    Ataxia scale A high score describes strong ataxia and a low score describes weak ataxia

    Measured: Day 1

  12. Fugl Meyer Upper extremity test

    Tests impairments of the upper limb after stroke

    Measured: Day 2

  13. Corsi block

    Tests the visuo-spatial memory

    Measured: Day 2

  14. Montreal Cognitive Assessment (MoCA)

    Tests the short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space

    Measured: Day 2

  15. Abilhand and activlim

    Questionnaire about the bimanual hability during activities of the daily life

    Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start29 Jan 2021
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Evaluation of bimanual motor skill learning
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642599
Sponsor's protocol ID
BimMSkL-Cerebellum
Status last verified
Dec 2024
First submitted
2 Nov 2020
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: the precise IPD plan has to be worked out in order to find the best public repository

Publications

  • 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.

    PubMed 29326573

  • 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.

    PubMed 29420360

  • 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.

    PubMed 31088342

  • 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.

    PubMed 38722346

Questions about this trial

What is this clinical trial studying?

A study testing Bimanual motor skill learning with the REAplan® rehabilitation robot in people with Chronic Cerebellar Stroke and Healthy Individuals (Controls), run by University Hospital of Mont-Godinne at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in bi-SAT (time frame: Change between day 1 to 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04642599, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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