Clinical trial NCT04642599: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
name: Université Catholique de Louvain
name: Louvain Bionics, UCLouvain
First posted: 2020-11-24
Enrollment: 50
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
Primary purpose: BASIC_SCIENCE

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®.

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

Primary outcomes:
measure: Change in bi-SAT
timeFrame: Change between day 1 to 3
measure: Change in bi-CO
timeFrame: Change between day 1 to 3
Secondary outcomes:
measure: bi-SAT
timeFrame: Day 1 + day 3
measure: bi-CO
timeFrame: Day 1 + day 3
measure: change in bi-Force
timeFrame: Change between day 1 to 3
measure: bi-Force
timeFrame: Day 1 + day 3
measure: bi-smoothness
timeFrame: Day 1+ day 3
measure: bi-error
timeFrame: Day 1 + day 3
measure: Dextrain
timeFrame: Day 1 + day 3
measure: Dextrain
timeFrame: Day 1 + day 3
measure: Dextrain
timeFrame: Day 1 + day 3
measure: BBT
timeFrame: Day 1 + day 3
measure: Modified International Cooperative Ataxia Rating Scale (MICARS)
timeFrame: Day 1
measure: Fugl Meyer Upper extremity test
timeFrame: Day 2
measure: Corsi block
timeFrame: Day 2
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Day 2
measure: Abilhand and activlim
timeFrame: Day 3
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit
state: Namur
Study officials:
affiliation: University Hospital of Mont-Godinne
name: Yves 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: 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: 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.