Chronic Cerebellar Stroke Clinical Trial
Official title:
Bimanual Motor Skill Learning Through Robotics in Chronic Cerebellar Stroke Survivors and Healthy Individuals
| Verified date | January 2024 |
| Source | University Hospital of Mont-Godinne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit | Yvoir | Namur |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of Mont-Godinne | Fonds National de la Recherche Scientifique, Louvain Bionics, UCLouvain, Université Catholique de Louvain |
Belgium,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 between day 1 to 3 | |
| Primary | 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 | Change between day 1 to 3 | |
| Secondary | bi-SAT | On bimanual REACHING (REAplan robot) bimanual Speed/Accurady Trade-off: mathematical computation of the relationship | Day 1 + day 3 | |
| Secondary | bi-CO | On bimanual REACHING (REAplan robot) bimanual Coordination factor: mathematical measure of the phase coherence between velocities of both arms | Day 1 + day 3 | |
| Secondary | change in bi-Force | Bimanual forces : forces exerted in the wrong direction by each arm (Newtons) | Change between day 1 to 3 | |
| Secondary | bi-Force | On bimanual REACHING (REAplan robot) bimanual forces : forces exerted in the wrong direction by each arm (Newtons) |
Day 1 + day 3 | |
| Secondary | bi-smoothness | On bimanual REACHING (REAplan robot) Smoothness of movement : Spectral Arc Length (SPARC) | Day 1+ day 3 | |
| Secondary | bi-error | on bimanual REACHING (REAplan robot) Error in centimeters or degrees during bimanual reaching | Day 1 + day 3 | |
| Secondary | Dextrain | Kinetic device measuring the movements of each finger: error and co-activation (percentage) | Day 1 + day 3 | |
| Secondary | Dextrain | Kinetic device measuring the movements of each finger: speed (milliseconds) | Day 1 + day 3 | |
| Secondary | Dextrain | Kinetic device measuring the movements of each finger: force (Newton) | Day 1 + day 3 | |
| Secondary | BBT | Box & Blocks Test (timed transfert of blocks from one space to the other) | Day 1 + day 3 | |
| Secondary | Modified International Cooperative Ataxia Rating Scale (MICARS) | Ataxia scale A high score describes strong ataxia and a low score describes weak ataxia | Day 1 | |
| Secondary | Fugl Meyer Upper extremity test | Tests impairments of the upper limb after stroke | Day 2 | |
| Secondary | Corsi block | Tests the visuo-spatial memory | Day 2 | |
| Secondary | Montreal Cognitive Assessment (MoCA) | Tests the short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space | Day 2 | |
| Secondary | Abilhand and activlim | Questionnaire about the bimanual hability during activities of the daily life | Day 3 |