- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495998
The Motor Neurological Soft Signs (MNSS) in Persons With Schizophrenia (MNSS)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lisbon, Portugal
- Susana Guimarães
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have a schizophrenia diagnoses
Exclusion Criteria:
- Have a motor disability
- Drugs consumer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Motor Neurological Soft Signs
motor test and an interview for the participants
|
translate, adapt and validate Brief Motor Scale for portuguese population with schizophrenia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susana Guimarães, MD, Faculdade Motricidade Humana
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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