Cerebral PalsyNCT02543424
Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients
A study testing Motor, cognitive and neuropsychological assessment in people with Cerebral Palsy and Perceptual Disorders, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Perceptual Disorders, Hemiparesis
- What is being tested?
- Motor, cognitive and neuropsychological assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 2 sitesBelgium
- Study dates
- Apr 2015to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- IQ < 70
- Severe aphasia, attentional disorder or psychiatric disorders
- Neurodegenerative disorders
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marie Alsamour contact
Stéphanie Dehem contact
Belgium2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Neurologique William Lennox
Ottignies, Brabant Wallon, 1340
Sybille Andries
- Recruiting
Cliniques Universitaires St Luc
Woluwé-Saint-Lambert, Brussels Capital, 1200
Thierry Lejeune, Pr
About this study
Official title: Studies of the Diagnosis, Rehabilitation and Links Between Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients
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.
- Conditions
- Cerebral Palsy, Perceptual Disorders, Hemiparesis
- Being tested
- Motor, cognitive and neuropsychological assessment
- Medical subject headings
- Cerebral Palsy, Perceptual Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor, cognitive and neuropsychological assessmentBehavioural
Cognitive and motor testing and/or experimental cognitive or motor changes and/or cognitive or motor rehabilitation depending on part of the study investigated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motor, cognitive and neuropsychological assessment |
| Control group | Sham comparator | Healthy adults and children. Receives: Behavioral: Motor, cognitive and neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Cognition and motor performance will be also measured with standardized paper and pencil tests, scales and questionnaires using the three dimensions of the International Classification of Functioning (Body structure and function / Activity limitation / Participation restriction).
Measured: Change from Baseline (T0) in cognitive and motor assessment at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Lejeune, Principal investigator, St. Luc HospitalGaëtan Stoquart, Principal investigator, St. Luc HospitalMartin Edwards, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543424
- Sponsor's protocol ID
- 2015/10FEV/053
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2015
- Last updated
- 27 Apr 2026
- Results posted
- No
Publications
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.
PubMed 39849588Dehem 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.
PubMed 31498135Montedoro 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.
PubMed 30084880
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of the Diagnosis, Rehabilitation and Links Between Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients
- ClinicalTrials.gov ID
- NCT02543424
- Acronym / sponsor ID
- 2015/10FEV/053
- Conditions
- Cerebral Palsy, Perceptual Disorders, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Behavioral: Motor, cognitive and neuropsychological assessmentBrain damaged adults with either hemiparesis and/or hemineglect. Brain damaged children with developmental and/or acquired disease inducing hemiparesis and/or hemineglect. |
| Control group | Sham comparator | Behavioral: Motor, cognitive and neuropsychological assessmentHealthy adults and children. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- IQ < 70
- Severe aphasia, attentional disorder or psychiatric disorders
- Neurodegenerative disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor, cognitive and neuropsychological assessmentCognitive and motor testing and/or experimental cognitive or motor changes and/or cognitive or motor rehabilitation depending on part of the study investigated. | Behavioural | Control group, Patient group |
Primary outcome
Kinematics
Time frame: Change from Baseline (T0) in kinematics at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).
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.
1 secondary outcome
Standardized cognitive and motor assessment
Time frame: Change from Baseline (T0) in cognitive and motor assessment at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 39849588Doumas 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.
- Derived from this study: PubMed 31498135Dehem 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.
- Derived from this study: PubMed 30084880Montedoro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Alsamour contact
Stéphanie Dehem contact
Thierry Lejeune principal investigator
St. Luc Hospital
Gaëtan Stoquart principal investigator
St. Luc Hospital
Martin Edwards principal investigator
Université Catholique de Louvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor, cognitive and neuropsychological assessment in people with Cerebral Palsy and Perceptual Disorders, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Alsamour (marie.alsamour@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics (time frame: Change from Baseline (T0) in kinematics at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02543424, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.