Bimanual Motor Skill Learning Through Robotics in Chronic Cerebellar Stroke Survivors and Healthy Individuals
December 10, 2024 updated by: Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
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).
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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®.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Namur
-
Yvoir, Namur, Belgium, 5530
- CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
STROKE PATIENTS:
Inclusion Criteria:
- having a chronic cerebellar stroke (>6 months)
- aged 18-90 years
- with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging
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:
Inclusion Criteria:
- 18-90 years
Exclusion Criteria:
- neurological conditions interfering with the study
- drug/alcohol abuse
- pyschiatric condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chronic Cerebellar Stroke
Participants with a chronic cerebellar stroke
|
REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements
|
|
Active Comparator: Healthy Individuals (Controls)
healthy participants
|
REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in bi-SAT
Time Frame: Change between day 1 to 3
|
Bimanual Speed/Accuracy Trade-off measured by the REAplan robot bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship bewteen speed and accuracy
|
Change between day 1 to 3
|
|
Change in bi-CO
Time Frame: Change between day 1 to 3
|
Bimanual Coordination factor measured by the REAplan robot bimanual Coordination factor : mathematical measure of the phase coherence between velocities of both arms
|
Change between day 1 to 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bi-SAT
Time Frame: Day 1 + day 3
|
On bimanual REACHING (REAplan robot) bimanual Speed/Accurady Trade-off: mathematical computation of the relationship
|
Day 1 + day 3
|
|
bi-CO
Time Frame: Day 1 + day 3
|
On bimanual REACHING (REAplan robot) bimanual Coordination factor: mathematical measure of the phase coherence between velocities of both arms
|
Day 1 + day 3
|
|
change in bi-Force
Time Frame: Change between day 1 to 3
|
Bimanual forces : forces exerted in the wrong direction by each arm (Newtons)
|
Change between day 1 to 3
|
|
bi-Force
Time Frame: Day 1 + day 3
|
On bimanual REACHING (REAplan robot) bimanual forces : forces exerted in the wrong direction by each arm (Newtons) |
Day 1 + day 3
|
|
bi-smoothness
Time Frame: Day 1+ day 3
|
On bimanual REACHING (REAplan robot) Smoothness of movement : Spectral Arc Length (SPARC)
|
Day 1+ day 3
|
|
bi-error
Time Frame: Day 1 + day 3
|
on bimanual REACHING (REAplan robot) Error in centimeters or degrees during bimanual reaching
|
Day 1 + day 3
|
|
Dextrain
Time Frame: Day 1 + day 3
|
Kinetic device measuring the movements of each finger: error and co-activation (percentage)
|
Day 1 + day 3
|
|
Dextrain
Time Frame: Day 1 + day 3
|
Kinetic device measuring the movements of each finger: speed (milliseconds)
|
Day 1 + day 3
|
|
Dextrain
Time Frame: Day 1 + day 3
|
Kinetic device measuring the movements of each finger: force (Newton)
|
Day 1 + day 3
|
|
BBT
Time Frame: Day 1 + day 3
|
Box & Blocks Test (timed transfert of blocks from one space to the other)
|
Day 1 + day 3
|
|
Modified International Cooperative Ataxia Rating Scale (MICARS)
Time Frame: Day 1
|
Ataxia scale A high score describes strong ataxia and a low score describes weak ataxia
|
Day 1
|
|
Fugl Meyer Upper extremity test
Time Frame: Day 2
|
Tests impairments of the upper limb after stroke
|
Day 2
|
|
Corsi block
Time Frame: Day 2
|
Tests the visuo-spatial memory
|
Day 2
|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: Day 2
|
Tests the short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space
|
Day 2
|
|
Abilhand and activlim
Time Frame: Day 3
|
Questionnaire about the bimanual hability during activities of the daily life
|
Day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2021
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
November 2, 2020
First Submitted That Met QC Criteria
November 18, 2020
First Posted (Actual)
November 24, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 10, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BimMSkL-Cerebellum
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
the precise IPD plan has to be worked out in order to find the best public repository
IPD Sharing Time Frame
Up to 2 years after publication of the scientific articles
IPD Sharing Access Criteria
none (public)
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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