search
Back to results

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

Primary Purpose

Stroke

Status
Recruiting
Phase
Early Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Bimanual motor skill learning with the REAplan(R) 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 Stroke

Eligibility Criteria

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

STROKE PATIENTS :

Inclusion Criteria:

  • having a chronic stroke (>6 months)
  • aged 18-90 years
  • with demonstrate a stroke 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
  • botulinum toxin injections (to be evaluated)

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 UnitRecruiting
  • Department of Neurology, CHU Mont-GodinneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention

control intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot
bimanual Speed/Accurady Trade-off: mathematical computation of the relationship bewteen speed and accuracy
bi-CO, bimanual Coordination factor measured by the REAplan robot
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms
bi-Force, bimanual Coordination factor measured by the REAplan robot
bimanual forces, forces exerted in the wrong direction by each arm (Newtons)

Secondary Outcome Measures

bi-SAT on bimanual REACHING (REAplan robot)
bimanual Speed/Accurady Trade-off: mathematical computation of the relationship
bi-Force on bimanual REACHING (REAplan robot)
bimanual forces, forces exerted in the wrong direction by each arm (Newtons)
bi-CO on bimanual REACHING (REAplan robot)
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms
bi-smoothness on bimanual REACHING (REAplan robot)
Smoothness of movement : Spectral Arc Length (SPARC)
bi-error on bimanual REACHING (REAplan robot)
Error in centimeres or degrees during bimanual reaching
BBT
Box & Blocks Test (timed transfert of blocks from one space to the other, 3 trials/hand)
whole-hand GF
whole-hand Grip Force (GF) measured with a dynamometer, 3 trials/hand)
Visual Analog Scale for fatigue (VAS fatigue)
Visual Analog Scale to evaluate fatigue = a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Range : 0- 10.

Full Information

First Posted
May 28, 2019
Last Updated
May 27, 2022
Sponsor
University Hospital of Mont-Godinne
Collaborators
Université Catholique de Louvain
search

1. Study Identification

Unique Protocol Identification Number
NCT03974750
Brief Title
Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
Acronym
bimMsKL
Official Title
Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne
Collaborators
Université Catholique de Louvain

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 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
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, ...).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Evaluation of bimanual motor skill learning Motor skill learning with a rehabilitation robot
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
Training on the rehabilitation robot REAplan(R) to learn complex, coordinated bimanual movements
Arm Title
control intervention
Arm Type
Active Comparator
Arm Description
Training on the rehabilitation robot REAplan(R) with simple movements
Intervention Type
Device
Intervention Name(s)
Bimanual motor skill learning with the REAplan(R) rehabilitation robot
Intervention Description
REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements
Primary Outcome Measure Information:
Title
bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot
Description
bimanual Speed/Accurady Trade-off: mathematical computation of the relationship bewteen speed and accuracy
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
bi-CO, bimanual Coordination factor measured by the REAplan robot
Description
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
bi-Force, bimanual Coordination factor measured by the REAplan robot
Description
bimanual forces, forces exerted in the wrong direction by each arm (Newtons)
Time Frame
change between baseline (Day 1) and after training (Day 3)
Secondary Outcome Measure Information:
Title
bi-SAT on bimanual REACHING (REAplan robot)
Description
bimanual Speed/Accurady Trade-off: mathematical computation of the relationship
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
bi-Force on bimanual REACHING (REAplan robot)
Description
bimanual forces, forces exerted in the wrong direction by each arm (Newtons)
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
bi-CO on bimanual REACHING (REAplan robot)
Description
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
bi-smoothness on bimanual REACHING (REAplan robot)
Description
Smoothness of movement : Spectral Arc Length (SPARC)
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
bi-error on bimanual REACHING (REAplan robot)
Description
Error in centimeres or degrees during bimanual reaching
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
BBT
Description
Box & Blocks Test (timed transfert of blocks from one space to the other, 3 trials/hand)
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
whole-hand GF
Description
whole-hand Grip Force (GF) measured with a dynamometer, 3 trials/hand)
Time Frame
change between baseline (Day 1) and after training (Day 3)
Title
Visual Analog Scale for fatigue (VAS fatigue)
Description
Visual Analog Scale to evaluate fatigue = a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Range : 0- 10.
Time Frame
change between baseline (Day 1) and after training (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 stroke (>6 months) aged 18-90 years with demonstrate a stroke 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 botulinum toxin injections (to be evaluated) HEALTHY INDIVIDUALS : Inclusion Criteria: - 18-90 years Exclusion Criteria: neurological conditions interfering with the study drug/alcohol abuse pyschiatric condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves Vandermeeren, MD, PhD
Phone
+3281423321
Email
yves.vandermeeren@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Y Vandermeeren, MD, PhD
Organizational Affiliation
Université catholique de Louvain, Institute of NeuroScience (IONS) NEUR / CHU
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Vandermeeren, MD, PhD
Phone
+32 81 42 3321
Email
yves.vandermeeren@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Mie Leeuwerck, PT
First Name & Middle Initial & Last Name & Degree
Audrey Riga, MSc
First Name & Middle Initial & Last Name & Degree
Damien Bontemps, student
First Name & Middle Initial & Last Name & Degree
Nicolas-Thomas Babuin, student
Facility Name
Department of Neurology, CHU Mont-Godinne
City
Yvoir
State/Province
Namur
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Vandermeeren, MD,PhD
Phone
081 42 3321
Ext
+32
Email
yves.vandermeeren@uclouvain.be

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
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
background
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
35300709
Citation
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.
Results Reference
derived
PubMed Identifier
33433485
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs