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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03280810
Other study ID # 1708158
Secondary ID
Status Completed
Phase N/A
First received September 11, 2017
Last updated September 13, 2017
Start date December 2013
Est. completion date December 2015

Study information

Verified date September 2017
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Movement group
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

Locations

Country Name City State
France Chu Saint-Etienne St Etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
At 8 weeks
Secondary 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). At 8 weeks
Secondary 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®). At 8 weeks
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