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

Study Contact Backup

Study Locations

  • Belgium
    • 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.
Behavioral: Motor, cognitive and neuropsychological assessment
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.
Behavioral: Motor, cognitive and neuropsychological assessment
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.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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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