Recruiting NCT03974750
Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bimanual motor skill learning with the REAplan(R) rehabilitation robot.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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, ...).
Interventions
- Device Bimanual motor skill learning with the REAplan(R) rehabilitation robot
REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements
Primary outcome measures
- bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot [Time frame: change between baseline (Day 1) and after training (Day 3)]
- bi-CO, bimanual Coordination factor measured by the REAplan robot [Time frame: change between baseline (Day 1) and after training (Day 3)]
- bi-Force, bimanual Coordination factor measured by the REAplan robot [Time frame: change between baseline (Day 1) and after training (Day 3)]
Secondary outcome measures (8)
- bi-SAT on bimanual REACHING (REAplan robot) [Time frame: change between baseline (Day 1) and after training (Day 3)]
- bi-Force on bimanual REACHING (REAplan robot) [Time frame: change between baseline (Day 1) and after training (Day 3)]
- bi-CO on bimanual REACHING (REAplan robot) [Time frame: change between baseline (Day 1) and after training (Day 3)]
- bi-smoothness on bimanual REACHING (REAplan robot) [Time frame: change between baseline (Day 1) and after training (Day 3)]
- bi-error on bimanual REACHING (REAplan robot) [Time frame: change between baseline (Day 1) and after training (Day 3)]
- BBT [Time frame: change between baseline (Day 1) and after training (Day 3)]
- whole-hand GF [Time frame: change between baseline (Day 1) and after training (Day 3)]
- Visual Analog Scale for fatigue (VAS fatigue) [Time frame: change between baseline (Day 1) and after training (Day 3)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Belgium · 2 centers
- CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit — Yvoir
- Department of Neurology, CHU Mont-Godinne — Yvoir
Publications
- 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. PMID 29326573
- 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. PMID 31088342
- 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. PMID 29420360
- 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. PMID 35300709
- 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. PMID 33433485
Identifiers
NCT: NCT03974750 · bimMsKL