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CompletedNCT03280810Updated Sep 14, 2017

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

An interventional study of Movement group in Schizophrenia, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia
  • Postural
  • Cognitive
  • task
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

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

Interventions

  • OtherMovement 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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: At 8 weeks

Secondary outcomes

  1. 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).

    Time frame: At 8 weeks

  2. 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®).

    Time frame: At 8 weeks

06

Study locations

1 site
  • Chu Saint-Etienne
    St Etienne, 42055, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03280810
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Dec 2013
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Sep 14, 2017

Study contacts

Catherine MASSOUBRE, PhD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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