Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Movement group
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring Schizophrenia, Postural, Cognitive, task
Eligibility Criteria
Inclusion Criteria:
- a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of schizophrenia (men or women)
- Men or woman aged 18-55
- Patients with no change in antipsychotic medication and clinical status within four weeks prior to the study
- Affiliates or entitled to a social security scheme
- Have given their informed consent before participating in the study.
Exclusion Criteria:
- Intelligence Quotient below 70 (score PM38)
- History of head trauma, neurological disease or not stabilized serious physical illness
- Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months.
Sites / Locations
- Chu Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Movement group
Control group
Arm Description
patients with schizophrenia (experimental group) have psycho-corporal training once a week, during 1 hour and a half for a period of two months
No intervervention : patients with schizophrenia (comparator group) who don't have psycho-corporal training
Outcomes
Primary Outcome Measures
the losses of postural and attentional control
To analyze the losses of postural and attentional control under dual-task condition.
Losses of postural and attentional control are calculated by one composite score named mu (Baddeley, Della Sala, Papagno, & Spinnler, 1997).
Secondary Outcome Measures
cognitive decrement
To compare mean values of the cognitive decrement between baseline and 8 weeks in which the Redundancy value of the responses sequence to the random number generation task were analyzed using RgCalc® software (Towse & Neil, 1998).
postural decrement
To compare mean values of the postural decrement between baseline and 8 weeks in which the confidence Ellipse is used as main criteria to evaluate the participants balance ability postural sway platform (WIN-POSTURO Médicapteurs®).
Full Information
NCT ID
NCT03280810
First Posted
September 11, 2017
Last Updated
September 13, 2017
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT03280810
Brief Title
Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
Official Title
Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Beside these well-known symptoms (positive symptoms (such as delirium and delusions), negative symptoms (such as affective flattening and impoverishment of speech), disorganized behavior, patients with schizophrenia show different kinds of cognitive alterations and motor abnormalities. In schizophrenia, postural impairment could increase the attentional cost of daily motor tasks, leading to a lack of attentional resources, essential to achieve complex cognitive tasks. The intrication of cognitive and postural processings (both impaired in schizophrenia) can be explored by using of a dual-task paradigm.
Detailed Description
This study assesses a psycho-corporal training (8 weeks psycho-corporal training) benefits on both postural (increased automation of balance control) and cognitive processings (smaller impact of the dual-task condition on attentional performances) in population of patients suffering from schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Postural, Cognitive, task
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Movement group
Arm Type
Experimental
Arm Description
patients with schizophrenia (experimental group) have psycho-corporal training once a week, during 1 hour and a half for a period of two months
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervervention : patients with schizophrenia (comparator group) who don't have psycho-corporal training
Intervention Type
Other
Intervention Name(s)
Movement group
Intervention Description
Experimental group : patients with schizophrenia who realise psycho-corporal training once a week, during 1 hour and a half for a period of two months
Primary Outcome Measure Information:
Title
the losses of postural and attentional control
Description
To analyze the losses of postural and attentional control under dual-task condition.
Losses of postural and attentional control are calculated by one composite score named mu (Baddeley, Della Sala, Papagno, & Spinnler, 1997).
Time Frame
At 8 weeks
Secondary Outcome Measure Information:
Title
cognitive decrement
Description
To compare mean values of the cognitive decrement between baseline and 8 weeks in which the Redundancy value of the responses sequence to the random number generation task were analyzed using RgCalc® software (Towse & Neil, 1998).
Time Frame
At 8 weeks
Title
postural decrement
Description
To compare mean values of the postural decrement between baseline and 8 weeks in which the confidence Ellipse is used as main criteria to evaluate the participants balance ability postural sway platform (WIN-POSTURO Médicapteurs®).
Time Frame
At 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of schizophrenia (men or women)
Men or woman aged 18-55
Patients with no change in antipsychotic medication and clinical status within four weeks prior to the study
Affiliates or entitled to a social security scheme
Have given their informed consent before participating in the study.
Exclusion Criteria:
Intelligence Quotient below 70 (score PM38)
History of head trauma, neurological disease or not stabilized serious physical illness
Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine MASSOUBRE, PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
St Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
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