Exploring Motor Learning in Acute Stroke Through Robotics

Exploring Motor Learning in Acute Stroke Through Robotics

Patrocinadores

Patrocinador principal: University Hospital of Mont-Godinne

Fuente University Hospital of Mont-Godinne
Resumen breve

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. To test the capacity of acute stroke patients (< 21 days) to learn and retain a complex unimanual motor skill.

2. To explore whether acute stroke to different brain regions (quantified with brain MRI) induces specific deficits in motor skill learning.

3. To compare acute stroke patients with healthy individuals and with chronic stroke patients.

Descripción detallada

Over 3 consecutive days, the subjects will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/). They will practice 2 serious games on the robot.

In order to differentiate the effect of motor control recovery from that of MskL, the acute stroke patients will be randomised 4/1 to "MskL" (n=120) or to "motor control recovery" (n=30) with a minimisation software. The experimental design will be similar except that the "motor control recovery" group will practice the serious game EASY instead of CIRCUIT (see below). The performances on both EASY & CIRCUIT will be compared between groups (subjects in both groups will perform the EASY & CIRCUIT tasks).The total time of rehabilitation will be the same.

The motor skill learning setup (CIRCUIT + EASY) that we developed and successfully used in healthy individuals and stroke patients has already been implemented in the REAplan environment and will be used as innovative serious games based on a speed/accuracy trade-off (SAT), allowing a detailed analysis of motor skill learning components (speed, accuracy, SAT, movement smoothness, dynamics...). For the serious game CIRCUIT, who based on motor skill learning, the subjects will have to practice a complex circuit and move as a cursor quickly and accurately as possible by controlling the handle of the robot with their affected hand/arm. For the other task EASY (a brick busters serious game), the aim will be to go back and forth between walls presented in different locations.

The subacute stroke phase is a unique opportunity to investigate the role of brain structures in motor learning/control. Compared to chronic impairments (> 6 months post-stroke), the subacute phase provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. To clarify the role of different brain structures in MskL, Voxel-based Lesion Symptom Mapping (VLSM) based on high-resolution brain magnetic resonance imaging (MRI) scans, will be used to analyse the relationship between tissue damage and MskL scores on a voxel-by-voxel basis.

In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions. The subjects will practice serious games on the robot REAplan (R), requiring movements with the affected arm (unimanual tasks).

In addition to the (sub)acute stroke patients, 2 others groups will be recruited for this study : a group of chronic stroke patients (stroke > 6 months) who will not be hospitalized and will not undergo MRI (N=30), and a group of healthy individuals who will not undergo MRI (N=50). Subjects in these 2 groups will be randomized 1/1 in the two arms ("MSkL" versus "motor control recovery" arms).

Estado general Recruiting
Fecha de inicio January 1, 2020
Fecha de Terminación July 1, 2023
Fecha de finalización primaria November 1, 2022
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
change in SAT (CIRCUIT) change between Baseline D1 and D3 (acute) + between Baseline D1 and 3/6 and 12 months post-stroke (subacute - chronic)
change in SPARC (EASY) change between Baseline D1 and D3 (acute) + between Baseline D1 and 3/6 and 12 months post-stroke (subacute - chronic)
Resultado secundario
Medida Periodo de tiempo
Tests motor control of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING) change between Baseline D1 and D3 (acute) + between Baseline D1 and 3/6 and 12 months post-stroke (subacute - chronic)
Tests motor control of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING) change between Baseline D1 and D3 (acute) + between Baseline D1 and 3/6 and 12 months post-stroke (subacute - chronic)
Tests motor control of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING) change between Baseline D1 and D3 (acute) + between Baseline D1 and 3/6 and 12 months post-stroke (subacute - chronic)
Fugl Meyer Upper Extremity Test change between Baseline D1 and D3 (acute) + between Baseline D1 and 3/6 and 12 months post-stroke (subacute - chronic)
Arm Motor Ability (AMA) test change between Baseline D1 and D3 (acute) + between Baseline D1 and 3/6 and 12 months post-stroke (subacute - chronic)
Fatigue Visual Analog Scale (VAS) change between Baseline D1 and D3 (acute) + between Baseline D1 and 3/6 and 12 months post-stroke (subacute - chronic)
Voxel-based Lesion Symptom Mapping (VLSM) Baseline
Inscripción 230
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: REAplan(R)

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

Elegibilidad

Criterios:

ACUTE STROKE PATIENTS:

Inclusion Criteria:

- acute stroke (> 21 days)

- aged 18-90 years

- with a stroke lesion on brain imaging

Exclusion Criteria:

- " 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

HEALTHY INDIVIDUALS:

Inclusion Criteria:

• 18-90 years

Exclusion Criteria:

- medical history with a previous stroke/neurological deficit

- drug/alcohol abuse

- psychiatric condition/ dementia

CHRONIC STROKE PATIENTS:

Inclusion Criteria:

- chronic stroke (>6 months)

- aged 18-90 years

- with 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

Género: All

Edad mínima: 18 Years

Edad máxima: 90 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Contacto general

Apellido: Yves Vandermeeren, MD, PhD

Teléfono: +32 81 42 33 21

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto:
CHU UCL Namur | Yvoir, Namur, 5530, Belgium Recruiting Eloïse Gerardin +3281423348 [email protected]
University Hospital CHU Dinant Godinne UCL | Yvoir, 5530, Belgium Not yet recruiting Yves Vandermeeren, MD, PhD [email protected]
Ubicacion Paises

Belgium

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University Hospital of Mont-Godinne

Nombre completo del investigador: Pr Yves Vandermeeren, MD, PhD

Título del investigador: Principal Investigator

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Motor Skill Learning (CIRCUIT)

Tipo: Experimental

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

Etiqueta: Motor control recovery (EASY)

Tipo: Active Comparator

Descripción: 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.

Datos del paciente Undecided
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Basic Science

Enmascaramiento: Single (Participant)

Fuente: ClinicalTrials.gov