Clinical trial NCT03974750: Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
Official title: Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
Collaborators: name: Université Catholique de Louvain
First posted: 2019-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluation of bimanual motor skill learning Motor skill learning with a rehabilitation robot
Primary purpose: BASIC_SCIENCE

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, ...).

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

Primary outcomes:
measure: bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: bi-CO, bimanual Coordination factor measured by the REAplan robot
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: bi-Force, bimanual Coordination factor measured by the REAplan robot
timeFrame: change between baseline (Day 1) and after training (Day 3)
Secondary outcomes:
measure: bi-SAT on bimanual REACHING (REAplan robot)
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: bi-Force on bimanual REACHING (REAplan robot)
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: bi-CO on bimanual REACHING (REAplan robot)
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: bi-smoothness on bimanual REACHING (REAplan robot)
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: bi-error on bimanual REACHING (REAplan robot)
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: BBT
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: whole-hand GF
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: Visual Analog Scale for fatigue (VAS fatigue)
timeFrame: change between baseline (Day 1) and after training (Day 3)
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit
state: Namur
city: Yvoir
country: Belgium
facility: Department of Neurology, CHU Mont-Godinne
state: Namur
Study officials:
affiliation: Université catholique de Louvain, Institute of NeuroScience (IONS) NEUR / CHU
name: Yves Y Vandermeeren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.