NCT03280810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

September 11, 2017

Last Update Submit

September 13, 2017

Conditions

Keywords

SchizophreniaPosturalCognitivetask

Outcome Measures

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).

    At 8 weeks

Secondary Outcomes (2)

  • cognitive decrement

    At 8 weeks

  • postural decrement

    At 8 weeks

Study Arms (2)

Movement group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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

Movement group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Catherine MASSOUBRE, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations