Physical TherapyNCT05533177
Effect Analysis of Physical Therapy Based on Electronic Medical Record
An observational study of Physical Therapy, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physical Therapy
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2022to 31 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
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.
- Conditions
- Physical Therapy
- Keywords
- rTMS, big data analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start23 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao No. 7 People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yiru Fang, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533177
- Sponsor's protocol ID
- 20220321
- Status last verified
- Mar 2022
- First submitted
- 26 Mar 2022
- Last updated
- 8 Sep 2022
- Results posted
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Analysis of Physical Therapy Based on Electronic Medical Record
- ClinicalTrials.gov ID
- NCT05533177
- Acronym / sponsor ID
- 20220321
- Conditions
- Physical Therapy
- Keywords
- rTMS, big data analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Qingdao No. 7 People's Hospital
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Sep 2022 (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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- 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.
Yiru Fang principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Therapy, run by Shanghai Mental Health Center at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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 China. 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?
Results are not available in the source record.
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?
Times of outpatients visit of patients with different types of mental disorders treated with rTMS (time frame: At December 2022). The study lists 5 primary outcomes in all. 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 8 Sep 2022.