UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027597 |
|---|---|
| Receipt number | R000031545 |
| Scientific Title | Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2018/02/06 22:24:04 |
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Basic information
Public title
Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Acronym
Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Scientific Title
Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Scientific Title:Acronym
Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We determine the advantage of effects of physical therapy intervention in every other day, as compared with five times a week.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Barthel Index (BI)
-Bedside Mobility Scale (BMS)
-10m maximum walking test
-Range of Motion Test
-Grip strength Test
Key secondary outcomes
-Brief Assessment of Cognition in Schizophrenia (BACS)
-Brief Psychiatric Rating Scale (BPRS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention: physical therapy intervention of three times a week by every other day
Interventions/Control_2
Control: physical therapy intervention of five times a week
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Patients who are unable to walk independently
-Patients who had a diagnosis of schizophrenia by DSM 1-5
-Patients whose written informed consent had obtained (from them or their proxies)
Key exclusion criteria
-Advanced dementia
-After surgery such as trauma
-Dialysis
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Fuji |
Organization
Osaka University
Division name
Public Health, Graduate School of Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
+81-6-6879-3911
yosshi511114@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Fuji |
Organization
Osaka University
Division name
Public Health, Graduate School of Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
+81-6-6879-3911
Homepage URL
yosshi511114@yahoo.co.jp
Sponsor or person
Institute
Department of Psychiatry, Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪急性期・総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 01 | Day |
Last modified on
| 2018 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031545
