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

NCT04642599 | Active Not Recruiting

• 1 other identifier: BimMSkL-Cerebellum
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (15)

• bi-SAT

  Day 1 + day 3

• bi-CO

  Day 1 + day 3

• change in bi-Force

  Change between day 1 to 3

• bi-Force

  Day 1 + day 3

• bi-smoothness

  Day 1+ day 3

Study Arms (2)

Chronic Cerebellar Stroke

EXPERIMENTAL

Participants with a chronic cerebellar stroke

Device: Bimanual motor skill learning with the REAplan® rehabilitation robot

Healthy Individuals (Controls)

ACTIVE COMPARATOR

healthy participants

Device: Bimanual motor skill learning with the REAplan® rehabilitation robot

Interventions

Bimanual motor skill learning with the REAplan® rehabilitation robot DEVICE

REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements

Chronic Cerebellar Stroke; Healthy Individuals (Controls)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having a chronic cerebellar stroke (\>6 months)
• aged 18-90 years
• with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging

You may not qualify if:

• 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:
• years
• neurological conditions interfering with the study
• drug/alcohol abuse
• pyschiatric condition

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead
• Fonds National de la Recherche Scientifique: collaborator
• Université Catholique de Louvain: collaborator
• Louvain Bionics, UCLouvain: collaborator

Study Sites (1)

CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit

Yvoir, Namur, 5530, Belgium

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Gathy E, Cadiat N, Gerardin E, Lambert J, Herman B, Leeuwerck M, Bihin B, Vandermeeren Y. Bimanual coordinated motor skill learning in patients with a chronic cerebellar stroke. Exp Brain Res. 2024 Jun;242(6):1517-1531. doi: 10.1007/s00221-024-06830-x. Epub 2024 May 9.

  PMID: 38722346 DERIVED

MeSH Terms

Conditions

Stroke; Cerebellar Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yves Vandermeeren, MD, PhD

  University Hospital of Mont-Godinne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Evaluation of bimanual motor skill learning

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 24, 2020
• Study Start: January 29, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Up to 2 years after publication of the scientific articles
• Access Criteria: none (public)

Locations

BE (1)