- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02543424
Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients
October 27, 2020 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie Alsamour
- Email: marie.alsamour@uclouvain.be
Study Contact Backup
- Name: Stéphanie Dehem
- Email: stephanie.dehem@uclouvain.be
Study Locations
-
-
Brabant Wallon
-
Ottignies, Brabant Wallon, Belgium, 1340
- Recruiting
- Centre Hospitalier Neurologique William Lennox
-
Contact:
- Sybille Andries
-
-
Bruxelles
-
Woluwé-Saint-Lambert, Bruxelles, Belgium, 1200
- Recruiting
- Cliniques Universitaires St Luc
-
Contact:
- Thierry Lejeune, Pr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- IQ < 70
- Severe aphasia, attentional disorder or psychiatric disorders
- Neurodegenerative disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient group
Brain damaged adults with either hemiparesis and/or hemineglect.
Brain damaged children with developmental and/or acquired disease inducing hemiparesis and/or hemineglect.
|
Cognitive and motor testing and/or experimental cognitive or motor changes and/or cognitive or motor rehabilitation depending on part of the study investigated.
|
Sham Comparator: Control group
Healthy adults and children.
|
Cognitive and motor testing and/or experimental cognitive or motor changes and/or cognitive or motor rehabilitation depending on part of the study investigated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Baseline (T0) in kinematics at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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).
|
Change from Baseline (T0) in cognitive and motor assessment at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thierry Lejeune, St. Luc Hospital
- Principal Investigator: Gaëtan Stoquart, St. Luc Hospital
- Principal Investigator: Martin Edwards, Université Catholique de Louvain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
August 12, 2015
First Submitted That Met QC Criteria
September 3, 2015
First Posted (Estimate)
September 7, 2015
Study Record Updates
Last Update Posted (Actual)
October 28, 2020
Last Update Submitted That Met QC Criteria
October 27, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/10FEV/053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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