SchizophreniaNCT03280810
Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
A study testing Movement group in people with Schizophrenia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Movement group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Schizophrenia
- Being tested
- Movement group
- Keywords
- Schizophrenia, Postural, Cognitive, task
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Movement group |
| Control group | No intervention | No intervervention : patients with schizophrenia (comparator group) who don't have psycho-corporal training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 8 weeks
Secondary outcomes (2)
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).
Measured: At 8 weeks
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®).
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine MASSOUBRE, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280810
- Sponsor's protocol ID
- 1708158
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03280810
- Acronym / sponsor ID
- 1708158
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Postural, Cognitive, task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Movement group | Experimental | Other: Movement grouppatients with schizophrenia (experimental group) have psycho-corporal training once a week, during 1 hour and a half for a period of two months |
| Control group | No intervention | –No intervervention : patients with schizophrenia (comparator group) who don't have psycho-corporal training |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement groupExperimental group : patients with schizophrenia who realise psycho-corporal training once a week, during 1 hour and a half for a period of two months | Other | Movement group |
Primary outcome
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).
2 secondary outcomes
cognitive decrement
Time frame: At 8 weeks
postural decrement
Time frame: At 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine MASSOUBRE, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement group in people with Schizophrenia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the losses of postural and attentional control (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.