NCT02543424

Brief Summary

Neurological pathologies cause important and permanent disabilities in every day life. These pathologies can follow stoke, affecting two people per one thousand each year or cerebral palsy, affecting two births per one thousand each year. To date, the diagnosis and the rehabilitation of motor and cognitive problems has been carried out separately by different domains. For example, physiotherapists have focused on motor problems and neuropsychologists have focused on cognitive functions. However, a number of studies have demonstrated a link between motor and cognitive abilities in adults and children. The present study has three main aims: (1) to better evaluate motor and cognitive problems in brain damaged patients (all ages), (2) to understand the link between motor and cognitive abilities in patients and healthy participants and, (3) to propose new types of therapies based on the link between motor and cognitive functions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Apr 2015Dec 2028

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

13.7 years

First QC Date

August 12, 2015

Last Update Submit

April 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Kinematics

    Kinematics will be measured with a robotic tool called the REAplan. This tool is a distal effector robotic device that enables the patients to perform upper limb movements in a horizontal plane. The robot comprises a distal effector, a visual interface for the patient and a visual interface for the experimenter. It is fitted with incremental position sensors allowing the record of the distal effector's trajectory in the X and Y plane as function of time (125 Hz). From these records, all kind of quantitative and objective indices of upper limb quality of movement can be computed. Motor and cognitive tasks have been created on this device and have to be validated. These new tools on the robot provide a more accurate measure to better understand the participant's motor and cognitive functioning through kinematics analyses. Moreover, the robot can be used as a rehabilitative device, providing cognitive and motor assistance for specific exercises depending on participant performance.

    Change from Baseline (T0) in kinematics at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).

Secondary Outcomes (1)

  • Standardized cognitive and motor assessment

    Change from Baseline (T0) in cognitive and motor assessment at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).

Study Arms (2)

Patient group

EXPERIMENTAL

Brain damaged adults with either hemiparesis and/or hemineglect. Brain damaged children with developmental and/or acquired disease inducing hemiparesis and/or hemineglect.

Behavioral: Motor, cognitive and neuropsychological assessment

Control group

SHAM COMPARATOR

Healthy adults and children.

Behavioral: Motor, cognitive and neuropsychological assessment

Interventions

Cognitive and motor testing and/or experimental cognitive or motor changes and/or cognitive or motor rehabilitation depending on part of the study investigated.

Control groupPatient group

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Congenital cerebral palsy and acquired brain injury children and adult patients
  • Presenting upper limb paresis and/or hemineglect
  • Between the age of 3 to 90.
  • Able to understand and carry out simple verbal instruction

You may not qualify if:

  • IQ \< 70
  • Severe aphasia, attentional disorder or psychiatric disorders
  • Neurodegenerative disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Neurologique William Lennox

Ottignies, Brabant Wallon, 1340, Belgium

RECRUITING

Cliniques Universitaires St Luc

Woluwé-Saint-Lambert, Brussels Capital, 1200, Belgium

RECRUITING

Related Publications (3)

  • Doumas I, Lejeune T, Edwards M, Stoquart G, Vandermeeren Y, Dehez B, Dehem S. Clinical validation of an individualized auto-adaptative serious game for combined cognitive and upper limb motor robotic rehabilitation after stroke. J Neuroeng Rehabil. 2025 Jan 23;22(1):10. doi: 10.1186/s12984-025-01551-w.

  • Dehem S, Montedoro V, Brouwers I, Edwards MG, Detrembleur C, Stoquart G, Renders A, Heins S, Dehez B, Lejeune T. Validation of a robot serious game assessment protocol for upper limb motor impairment in children with cerebral palsy. NeuroRehabilitation. 2019;45(2):137-149. doi: 10.3233/NRE-192745.

  • Montedoro V, Alsamour M, Dehem S, Lejeune T, Dehez B, Edwards MG. Robot Diagnosis Test for Egocentric and Allocentric Hemineglect. Arch Clin Neuropsychol. 2019 Jun 1;34(4):481-494. doi: 10.1093/arclin/acy062.

MeSH Terms

Conditions

Cerebral PalsyPerceptual DisordersParesis

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Thierry Lejeune

    St. Luc Hospital

    PRINCIPAL INVESTIGATOR
  • Gaëtan Stoquart

    St. Luc Hospital

    PRINCIPAL INVESTIGATOR
  • Martin Edwards

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Alsamour

CONTACT

Stéphanie Dehem

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

September 7, 2015

Study Start

April 1, 2015

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations