Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients

Cerebral Palsy Clinical Trial

Official title:

Studies of the Diagnosis, Rehabilitation and Links Between Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02543424
• Other study ID #: 2015/10FEV/053
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Marie Alsamour
• Email: marie.alsamour[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiparesis
• Paresis
• Perceptual Disorders

Intervention

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.

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Neurologique William Lennox	Ottignies	Brabant Wallon
Belgium	Cliniques Universitaires St Luc	Woluwé-Saint-Lambert	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Change from Baseline (T0) in cognitive and motor assessment at an expected average of 1 week (T1), 2 months (T2) and 3 months (T3).