Psychomotor StatusMNSSNCT04495998
The Motor Neurological Soft Signs (MNSS) in Persons With Schizophrenia
A study testing Brief Motor Scale_portuguese version (BMS_pt) in people with Psychomotor Status and Schizophrenia, run by Faculdade de Motricidade Humana at 1 site in Portugal.
Trial summary
The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychomotor Status, Schizophrenia, Motor Skills Disorders
- What is being tested?
- Brief Motor Scale_portuguese version (BMS_pt)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2017to Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a schizophrenia diagnoses
Who cannot join
- Have a motor disability
- Drugs consumer
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of prevention and a better follow-up in the psychosocial rehabilitation processes of the person with schizophrenia.
Read the detailed description
The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of prevention and a better follow-up in the psychosocial rehabilitation processes of the person with schizophrenia.
It is therefore important to answer the following starting questions:
- How can MNSS be assessed and analysed in the Portuguese population with schizophrenia?
- How does the manifestation of MNSS differ between people with and without schizophrenia?
- Do the MNSS of people with schizophrenia vary according to their functionality level including the following areas of activity (Cognition, Mobility, Self-Care, Interpersonal Relations, Daily Activities and Participation) and their motor experiences?
- How can the information obtained by applying a validated assessment tool for this purpose be made operational as a procedure for psychomotor assessment and intervention with this population?
The following objectives have been defined to answer these questions, which guide the work:
- Translate, adapt and validate the BMS instrument (Jahn et al., 2006) for the Portuguese population with schizophrenia;
- Explore the relationship of MNSS with demographic variables (e.g.: age, gender, education), clinical-therapeutic variables (e.g.: age of diagnosis, number of hospitalizations, medication, type of support) and psychosocial variables (e.g.: functionality, satisfaction and well-being, motor experiences);
- Test a multifactorial model of the relationships between MNSS, demographic variables, functional clinical-therapeutic and psychosocial;
- Compare MNSS in people with schizophrenia and people from a healthy control group.
- Conditions
- Psychomotor Status, Schizophrenia, Motor Skills Disorders
- Being tested
- Brief Motor Scale_portuguese version (BMS_pt)
- Medical subject headings
- Status Epilepticus, Schizophrenia, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motor Scale_portuguese version (BMS_pt)Diagnostic test
translate, adapt and validate Brief Motor Scale for portuguese population with schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| Motor Neurological Soft Signs | Other | motor test and an interview for the participants Receives: Diagnostic Test: Brief Motor Scale_portuguese version (BMS_pt) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of persons with schizophrenia with Brief Motor Scale - Portuguese version (BMS_pt) instrument
The aim of this study was to translate, adapt and validate a Portuguese version of the Brief Motor Scale (BMS_pt) in people with schizophrenia (Jahn et al, 2006).
The participants (N=43) were evaluated twice with an interval of two weeks. In total, the sample collection lasted 6 weeks.
Scale used and caracteristics:
Unabbreviate title - Brief Motor Scale - Portuguese version Abbreviate title - BMS_pt Minimum value = 0; Maximum value = 2 Higher scores mean a worse outcome.
Scale description:
BMS_pt is a quantative test, which assessed motor neurological soft signs (MNSS) in two domains: motor coordination and motor sequencing. BMS_pt have a range score between 0 and 2 points for each item, domains and total score.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study startJan 2017
- Primary completionDec 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor StatusStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susana Guimarães, MD, Faculdade de Motricidade Humana
- Investigators
- Susana Guimarães, MD, Principal investigator, Faculdade Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495998
- Sponsor's protocol ID
- 32/2017
- Acronym
- MNSS
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2020
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Motor Neurological Soft Signs (MNSS) in Persons With Schizophrenia
- ClinicalTrials.gov ID
- NCT04495998
- Acronym / sponsor ID
- MNSS / 32/2017
- Conditions
- Psychomotor Status, Schizophrenia, Motor Skills Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 3 Aug 2020 (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.
The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of prevention and a better follow-up in the psychosocial rehabilitation processes of the person with schizophrenia.
Detailed description
The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of prevention and a better follow-up in the psychosocial rehabilitation processes of the person with schizophrenia.
It is therefore important to answer the following starting questions:
- How can MNSS be assessed and analysed in the Portuguese population with schizophrenia?
- How does the manifestation of MNSS differ between people with and without schizophrenia?
- Do the MNSS of people with schizophrenia vary according to their functionality level including the following areas of activity (Cognition, Mobility, Self-Care, Interpersonal Relations, Daily Activities and Participation) and their motor experiences?
- How can the information obtained by applying a validated assessment tool for this purpose be made operational as a procedure for psychomotor assessment and intervention with this population?
The following objectives have been defined to answer these questions, which guide the work:
- Translate, adapt and validate the BMS instrument (Jahn et al., 2006) for the Portuguese population with schizophrenia;
- Explore the relationship of MNSS with demographic variables (e.g.: age, gender, education), clinical-therapeutic variables (e.g.: age of diagnosis, number of hospitalizations, medication, type of support) and psychosocial variables (e.g.: functionality, satisfaction and well-being, motor experiences);
- Test a multifactorial model of the relationships between MNSS, demographic variables, functional clinical-therapeutic and psychosocial;
- Compare MNSS in people with schizophrenia and people from a healthy control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motor Neurological Soft Signs | Other | Diagnostic Test: Brief Motor Scale_portuguese version (BMS_pt)motor test and an interview for the participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have a schizophrenia diagnoses
Key exclusion criteria (2 listed)
- Have a motor disability
- Drugs consumer
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 |
|---|---|---|
| Brief Motor Scale_portuguese version (BMS_pt)translate, adapt and validate Brief Motor Scale for portuguese population with schizophrenia | Diagnostic test | Motor Neurological Soft Signs |
Primary outcome
Assessment of persons with schizophrenia with Brief Motor Scale - Portuguese version (BMS_pt) instrument
Time frame: 6 weeks
The aim of this study was to translate, adapt and validate a Portuguese version of the Brief Motor Scale (BMS_pt) in people with schizophrenia (Jahn et al, 2006). The participants (N=43) were evaluated twice with an interval of two weeks. In total, the sample collection lasted 6 weeks. Scale used and caracteristics: Unabbreviate title - Brief Motor Scale - Portuguese version Abbreviate title - BMS_pt Minimum value = 0; Maximum value = 2 Higher scores mean a worse outcome. Scale description: BMS_pt is a quantative test, which assessed motor neurological soft signs (MNSS) in two domains: motor coordination and motor sequencing. BMS_pt have a range score between 0 and 2 points for each item, domains and total score.
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 2 Jun 2023.
- Validity and Reliability of the Portuguese Version of Brief Motor Scale in Persons with Schizophrenia: A Preliminary StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Susana Guimarães, MD principal investigator
Faculdade Motricidade Humana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motor Scale_portuguese version (BMS_pt) in people with Psychomotor Status and Schizophrenia, run by Faculdade de Motricidade Humana at 1 site in Portugal.
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 1 inclusion and 2 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 2 Jun 2023. 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 Portugal. 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?
Assessment of persons with schizophrenia with Brief Motor Scale - Portuguese version (BMS_pt) instrument (time frame: 6 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 2 Jun 2023.