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Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients

Primary Purpose

Cerebral Palsy, Perceptual Disorders, Hemiparesis

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Motor, cognitive and neuropsychological assessment
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Neurologique William LennoxRecruiting
  • Cliniques Universitaires St LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Patient group

Control group

Arm Description

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

Healthy adults and children.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
August 12, 2015
Last Updated
October 27, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02543424
Brief Title
Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients
Official Title
Studies of the Diagnosis, Rehabilitation and Links Between Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Perceptual Disorders, Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient group
Arm Type
Experimental
Arm Description
Brain damaged adults with either hemiparesis and/or hemineglect. Brain damaged children with developmental and/or acquired disease inducing hemiparesis and/or hemineglect.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Healthy adults and children.
Intervention Type
Behavioral
Intervention Name(s)
Motor, cognitive and neuropsychological assessment
Intervention Description
Cognitive and motor testing and/or experimental cognitive or motor changes and/or cognitive or motor rehabilitation depending on part of the study investigated.
Primary Outcome Measure Information:
Title
Kinematics
Description
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.
Time Frame
Change from Baseline (T0) in kinematics at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).
Secondary Outcome Measure Information:
Title
Standardized cognitive and motor assessment
Description
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).
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Alsamour
Email
marie.alsamour@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Dehem
Email
stephanie.dehem@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Lejeune
Organizational Affiliation
St. Luc Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaëtan Stoquart
Organizational Affiliation
St. Luc Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Edwards
Organizational Affiliation
Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Neurologique William Lennox
City
Ottignies
State/Province
Brabant Wallon
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sybille Andries
Facility Name
Cliniques Universitaires St Luc
City
Woluwé-Saint-Lambert
State/Province
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Lejeune, Pr

12. IPD Sharing Statement

Citations:
PubMed Identifier
31498135
Citation
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.
Results Reference
derived
PubMed Identifier
30084880
Citation
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.
Results Reference
derived

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Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients

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