Effect Analysis of Physical Therapy Based on Electronic Medical Record

September 5, 2022 updated by: Shanghai Mental Health Center
WHO has reported the heavy disease burden of psychiatric disorders. Due to the unsatisfactory effect of pharmacotherapy, physical therapy has attracted extensive attention as a complementary therapy. However, few large sample real-world studies are exploring its efficacy. This study intends to explore the efficacy of physical therapy in different types of mental disorders, which is meaningful for the formulation of personalized treatment plans.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis criteria of ICD-10 F20-F48 and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited

Description

Inclusion Criteria:

  • age is not limited
  • gender is not limited
  • meets the diagnostic criteria of ICD-10 F20-F48 and its sub-categories
  • has relevant HIS system data that can be utilized.
  • have been treated with physical therapy

Exclusion Criteria:

  • patients who did not meet the appeal diagnosis
  • patients who met the above three diagnoses but had severe data loss (missing value ≥ estimated data value of 30%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Schizophrenia, schizotypal and delusional disorders
Patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis of F20-F29 Schizophrenia、schizotypal and delusional disorders criteria and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited.
Mood disorders
Patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis of F30-F39 Mood disorders criteria and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited.
Neurotic, stress-related and somatoform disorders
Patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis of F40-F48 Neurotic、stress-related and somatoform disorders criteria and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Times of outpatients visit of patients with different types of mental disorders treated with rTMS
Time Frame: At December 2022
Based on electronic medical record (text profile), we will extract prognosis related information of patients treated with rTMS, namely, their times of outpatients visit.
At December 2022
Thyroid hormones changes of biochemical parameters after rTMS in patients with mental disorders
Time Frame: At March 2023
Based on electronic medical record (record of examination information), we will extract all the patients' records of thyroid hormones. Then analyze the changes of these parameters after rTMS to see if these changes are related to the prognosis of patients with mental disorders.
At March 2023
Liver function related indexes changes of biochemical parameters after rTMS in patients with mental
Time Frame: At March 2023
Base on electronic medical record (record of examination information), we will extract all the patients' records of liver function tests. Then analyze the changes of these parameters after rTMS to see if these changes are related to the prognosis of patients with mental disorders.
At March 2023
Duration of the whole outpatients visit of patients with different types of mental disorders treated with rTMS
Time Frame: At December 2022
Based on electronic medical record (text profile), we will extract prognosis related information of patients treated with rTMS, namely, the duration of the whole outpatients visit.
At December 2022
Changes of status description of patients with different types of mental disorders treated with rTMS
Time Frame: At December 2022
Based on electronic medical record (text profile), we will extract prognosis related information of patients treated with rTMS, namely, the changes of status description of disease.
At December 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Qingdao Mental Health Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yiru Fang, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20220321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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