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Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients

Primary Purpose

Chronic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroencephalographic,magnetic resonance imaging
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Stroke patients with ischaemia of the upper limb for less than 6 months
  • Patients with sensorimotor deficits

Exclusion Criteria:

  • Patients treated with botulinum toxin for less than 6 months
  • Alcoholic patients
  • Patients who had surgery on upper limb

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pateint with chronic stroke

Healthy volunteer

Arm Description

Outcomes

Primary Outcome Measures

Numbers of anomalies in the processing of movement-execution

Secondary Outcome Measures

Full Information

First Posted
August 24, 2016
Last Updated
August 24, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02881736
Brief Title
Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical assessment of motor and sensory deficits is still today largely based on tests that do not permit any precise quantification. However, robotic technologies, coupled with neuroimaging techniques constitute new tools to assess sensorimotor functions that could allow to conceive neurorehabilitation protocols better adapted to the neurological impairment of each patient and to her/his specific recovery profile. The goal of this project is to contribute identifying the factors that determine functional recovery in stroke patients presenting upper-limb motor deficits. Here, we will focus our research on two factors that contribute in a complementary way to motor control: 1) the processing of proprioceptive informations, and 2) the processing of movement-execution errors. In this purpose, we will combine psychophysical methods that allow to precisely quantify sensorimotor deficits with functional and anatomical neuroimaging techniques. More specifically, we will exploit experimental protocols that have been developed in basic research, that use a robotic exoskeleton coupled with a virtual reality device, to precisely quantify motor and proprioceptive deficits in stroke patients. Then, we will link these behavioral data to electroencephalographic (EEG) signals recorded during a motor adaptation task, as well as to anatomical data, namely conventional magnetic resonance imaging (MRI) completed by diffusion tensor images (DTI) in order to achieve a finer description of the cerebral lesions. The present study will include two experimental parts, respectively centered on the proprioceptive deficits (Part 1) and the anomalies in the processing of movement-execution errors (Part 2). Proprioceptive deficits in stroke patients : We will test the hypothesis that, when present, deficits in kinaesthesia and troubles in unconscious proprioception contribute substantially to motor deficits in stroke patients ; with as a corollary hypothesis, that deficits in " proprioception for action " are more determinant than deficits in the conscious sense of position (classically tested in clinics). In this purpose, we will collect three sets of behavioral data, in chronic stroke patients and healthy control participants, respectively intended to assess a) motor deficits, b) troubles in conscious sense of position, and c) deficits in "proprioception for action". To better document the neuronatomical substrates of these different types of deficits. In this purpose, we will link the obtained behavioral data with the results of detailed analyses of the lesions of the tested stroke patients. Anomalies in the processing of movement-execution errors in stroke patients : We will assess movement-execution error processing in stroke patients, in order to test the idea that anomalies in error processing might contribute to motor deficits in stroke patients. In this purpose, we will record an electrophysiological correlate (ERP) of movement-error processing during a motor adaptation task. We will analyse the relation between the modulation of this ERP and motor performance. We will also examine the relation between these two sets of data (behavioral and electrophysiological) and the behavioral data collected during the first part of the study (Proprioceptive deficits). This will provide us with insight into the relationship between proprioceptive deficits and cinematic error processing. As in the first part of the study, we will link the observed electrophysiological and behavioral anomalies with the results of a detailed analysis of the anatomical lesions of the tested patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pateint with chronic stroke
Arm Type
Experimental
Arm Title
Healthy volunteer
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
electroencephalographic,magnetic resonance imaging
Primary Outcome Measure Information:
Title
Numbers of anomalies in the processing of movement-execution
Time Frame
4hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Stroke patients with ischaemia of the upper limb for less than 6 months Patients with sensorimotor deficits Exclusion Criteria: Patients treated with botulinum toxin for less than 6 months Alcoholic patients Patients who had surgery on upper limb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle Desalbres
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laurent Bensoussan, MD/PhD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients

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