Effect Analysis of Physical Therapy Based on Electronic Medical Record

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: Active, not recruiting
• Conditions: Physical Therapy

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
Times of outpatients visit of patients with different types of mental disorders treated with rTMS	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	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	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	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	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

• Sponsor: Shanghai Mental Health Center
• Collaborators: Qingdao Mental Health Center
• Investigators: Principal Investigator: Yiru Fang, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: rTMS; big data analysis
• Other Study ID 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