Exploring Motor Learning in Acute Stroke Through Robotics

NCT04171856 | Recruiting

• 1 other identifier: B039201938990
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 2

Brief Summary

The acute phase of stroke is characterized by an enhancement of neural plasticity which supports rapid motor recovery. It is unclear whether acute stroke patients can acquire new motor skills with their affected upper limb. The aims of this research program are:

1. 1.To test the capacity of acute stroke patients (\< 21 days) to learn and retain a complex unimanual motor skill.
2. 2.To explore whether acute stroke to different brain regions (quantified with brain MRI) induces specific deficits in motor skill learning.
3. 3.To compare acute stroke patients with healthy individuals and with chronic stroke patients.

Conditions

Stroke, Acute

Keywords

Acute stroke; Motor skill learning; Upper limb; Rehabilitation; Subacute stroke

Outcome Measures

Primary Outcomes (2)

• change in SAT (CIRCUIT)

  Speed/ Accuracy Trade-off

  change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

• total distance travelled (EASY)

  total distance travelled between the walls of the brick busters (in cm)

  change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

Secondary Outcomes (11)

• Fugl Meyer Upper Extremity Test

  change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

• Arm Motor Ability (AMA) test

  change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

• Fatigue Visual Analog Scale (VAS)

  change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

• Voxel-based Lesion Symptom Mapping (VLSM)

  Baseline

• Dextrain®

  change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

Study Arms (3)

Motor Skill Learning (CIRCUIT)

EXPERIMENTAL

Intervention: training on the REAplan robot with a serious game based on motor skill learning (MSkL) serious game, the CIRCUIT.

Device: REAplan(R)

Motor control recovery (EASY)

ACTIVE COMPARATOR

Training on the REAplan robot with a serious game that requires similar type and amount of movements but does not rely on motor skill learning (EASY), a brick buster game.

Device: REAplan(R)

Conventional

ACTIVE COMPARATOR

Training sessions with classical exercices focused on the upper limb administered by occupation therapist.

Device: REAplan(R)

Interventions

REAplan(R) DEVICE

motor skill learning with the REAplan(R) rehabilitation robot, to be perfomed with the affected arm

Conventional; Motor Skill Learning (CIRCUIT); Motor control recovery (EASY)

Eligibility Criteria

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

You may qualify if:

• acute stroke (\> 21 days)
• aged 18-90 years
• with a stroke lesion on brain imaging

You may not qualify if:

• " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophoby, etc ...)
• 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
• PATIENTS WITH TRANSIENT GLOBAL AMNESIA:
• Clinical diagnosis, criteria of Hodge \& Warlow (1990):
• Anterograde amnesia observed by a witness
• No alteration of consciousness or loss of identity
• Cognitive dysfunction limited to amnesia
• Lack of focused neurological deficit or argument for a comitiality
• Absence of head trauma
• Symptom resolution within 24 hours
• Possible existence of vegetative symptoms

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

Study Sites (2)

CHU UCL Namur

Yvoir, Namur, 5530, Belgium

RECRUITING

University Hospital CHU Dinant Godinne UCL

Yvoir, 5530, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Yves Vandermeeren, MD, PhD

  UCLouvain IONS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Vandermeeren, MD, PhD

CONTACT

+32 81 42 33 21; yves.vandermeeren@uclouvain.be

Eloïse Gerardin, MSc

CONTACT

+32 81 42 33 48; eloise.gerardin@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 21, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): July 1, 2040
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available during thebeggining of the study and for 20 years.
• Access Criteria: Login user of the Hospital of CHU UCL Namur -Site Godinne

Locations

BE (2)