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Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT03280810
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Movement group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Movement group
patients with schizophrenia (experimental group) have psycho-corporal training once a week, during 1 hour and a half for a period of two months
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

No Intervention: Control group
No intervervention : patients with schizophrenia (comparator group) who don't have psycho-corporal training



Primary Outcome Measures :
  1. the losses of postural and attentional control [ Time Frame: At 8 weeks ]

    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 :
  1. cognitive decrement [ Time Frame: At 8 weeks ]
    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).

  2. postural decrement [ Time Frame: At 8 weeks ]
    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®).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280810


Locations
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France
Chu Saint-Etienne
St Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Catherine MASSOUBRE, PhD CHU SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03280810     History of Changes
Other Study ID Numbers: 1708158
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Schizophrenia
Postural
Cognitive
task
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders