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

Primary Purpose

Chronic Cerebellar Stroke, Healthy Individuals (Controls)

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Bimanual motor skill learning with the REAplan® rehabilitation robot
Sponsored by
University Hospital of Mont-Godinne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Cerebellar Stroke focused on measuring Stroke, Cerebellar Disorders, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Cerebellar Stroke, Cerebellar Hemorrhage, Cerebellar Infarction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chronic Cerebellar Stroke

Healthy Individuals (Controls)

Arm Description

Participants with a chronic cerebellar stroke

healthy participants

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

bi-SAT
On bimanual REACHING (REAplan robot) bimanual Speed/Accurady Trade-off: mathematical computation of the relationship
bi-CO
On bimanual REACHING (REAplan robot) bimanual Coordination factor: mathematical measure of the phase coherence between velocities of both arms
change in bi-Force
Bimanual forces : forces exerted in the wrong direction by each arm (Newtons)
bi-Force
On bimanual REACHING (REAplan robot) bimanual forces : forces exerted in the wrong direction by each arm (Newtons)
bi-smoothness
On bimanual REACHING (REAplan robot) Smoothness of movement : Spectral Arc Length (SPARC)
bi-error
on bimanual REACHING (REAplan robot) Error in centimeters or degrees during bimanual reaching
Dextrain
Kinetic device measuring the movements of each finger: error and co-activation (percentage)
Dextrain
Kinetic device measuring the movements of each finger: speed (milliseconds)
Dextrain
Kinetic device measuring the movements of each finger: force (Newton)
BBT
Box & Blocks Test (timed transfert of blocks from one space to the other)
Modified International Cooperative Ataxia Rating Scale (MICARS)
Ataxia scale A high score describes strong ataxia and a low score describes weak ataxia
Fugl Meyer Upper extremity test
Tests impairments of the upper limb after stroke
Corsi block
Tests the visuo-spatial memory
Montreal Cognitive Assessment (MoCA)
Tests the short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space
Abilhand and activlim
Questionnaire about the bimanual hability during activities of the daily life

Full Information

First Posted
November 2, 2020
Last Updated
June 8, 2023
Sponsor
University Hospital of Mont-Godinne
Collaborators
Fonds National de la Recherche Scientifique, Université Catholique de Louvain, Louvain Bionics, UCLouvain
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1. Study Identification

Unique Protocol Identification Number
NCT04642599
Brief Title
Bimanual Motor Skill Learning Through Robotics in Chronic Cerebellar Stroke Survivors and Healthy Individuals
Official Title
Bimanual Motor Skill Learning Through Robotics in Chronic Cerebellar Stroke Survivors and Healthy Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne
Collaborators
Fonds National de la Recherche Scientifique, Université Catholique de Louvain, Louvain Bionics, UCLouvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cerebellar Stroke, Healthy Individuals (Controls)
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Evaluation of bimanual motor skill learning
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic Cerebellar Stroke
Arm Type
Experimental
Arm Description
Participants with a chronic cerebellar stroke
Arm Title
Healthy Individuals (Controls)
Arm Type
Active Comparator
Arm Description
healthy participants
Intervention Type
Device
Intervention Name(s)
Bimanual motor skill learning with the REAplan® rehabilitation robot
Intervention Description
REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements
Primary Outcome Measure Information:
Title
Change in bi-SAT
Description
Bimanual Speed/Accuracy Trade-off measured by the REAplan robot bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship bewteen speed and accuracy
Time Frame
Change between day 1 to 3
Title
Change in bi-CO
Description
Bimanual Coordination factor measured by the REAplan robot bimanual Coordination factor : mathematical measure of the phase coherence between velocities of both arms
Time Frame
Change between day 1 to 3
Secondary Outcome Measure Information:
Title
bi-SAT
Description
On bimanual REACHING (REAplan robot) bimanual Speed/Accurady Trade-off: mathematical computation of the relationship
Time Frame
Day 1 + day 3
Title
bi-CO
Description
On bimanual REACHING (REAplan robot) bimanual Coordination factor: mathematical measure of the phase coherence between velocities of both arms
Time Frame
Day 1 + day 3
Title
change in bi-Force
Description
Bimanual forces : forces exerted in the wrong direction by each arm (Newtons)
Time Frame
Change between day 1 to 3
Title
bi-Force
Description
On bimanual REACHING (REAplan robot) bimanual forces : forces exerted in the wrong direction by each arm (Newtons)
Time Frame
Day 1 + day 3
Title
bi-smoothness
Description
On bimanual REACHING (REAplan robot) Smoothness of movement : Spectral Arc Length (SPARC)
Time Frame
Day 1+ day 3
Title
bi-error
Description
on bimanual REACHING (REAplan robot) Error in centimeters or degrees during bimanual reaching
Time Frame
Day 1 + day 3
Title
Dextrain
Description
Kinetic device measuring the movements of each finger: error and co-activation (percentage)
Time Frame
Day 1 + day 3
Title
Dextrain
Description
Kinetic device measuring the movements of each finger: speed (milliseconds)
Time Frame
Day 1 + day 3
Title
Dextrain
Description
Kinetic device measuring the movements of each finger: force (Newton)
Time Frame
Day 1 + day 3
Title
BBT
Description
Box & Blocks Test (timed transfert of blocks from one space to the other)
Time Frame
Day 1 + day 3
Title
Modified International Cooperative Ataxia Rating Scale (MICARS)
Description
Ataxia scale A high score describes strong ataxia and a low score describes weak ataxia
Time Frame
Day 1
Title
Fugl Meyer Upper extremity test
Description
Tests impairments of the upper limb after stroke
Time Frame
Day 2
Title
Corsi block
Description
Tests the visuo-spatial memory
Time Frame
Day 2
Title
Montreal Cognitive Assessment (MoCA)
Description
Tests the short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space
Time Frame
Day 2
Title
Abilhand and activlim
Description
Questionnaire about the bimanual hability during activities of the daily life
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)
Citations:
PubMed Identifier
29326573
Citation
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.
Results Reference
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PubMed Identifier
29420360
Citation
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.
Results Reference
background
PubMed Identifier
31088342
Citation
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.
Results Reference
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Bimanual Motor Skill Learning Through Robotics in Chronic Cerebellar Stroke Survivors and Healthy Individuals

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