UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011032 |
|---|---|
| Receipt number | R000011353 |
| Scientific Title | The effects of physical/occupational therapy after operations of the upper extremities on RA patients |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2013/06/25 11:04:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of physical/occupational therapy after operations of the upper extremities on RA patients
Acronym
PT/OT after upper extremity operations on RA patients
Scientific Title
The effects of physical/occupational therapy after operations of the upper extremities on RA patients
Scientific Title:Acronym
PT/OT after upper extremity operations on RA patients
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of physical/occupational therapy after operations of the upper extremity on RA patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DASH score
Key secondary outcomes
muscle strength, ROM, ADL score, QOL score, pain VAS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
an extended period of rehabilitation after operations of the upper extremity on RA patients
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, patients with rheumatoid arthritis
2, who undergo an operation of the upper extremity
3, who can visit regularly at the rehabilitation center
4, and who can answer questions in writing
Key exclusion criteria
1, patients with cognitive disorders
2, patients whom doctors or therapists regard inappropriate for this study
3, non-adults, or patients who cannot consent to this study of their own free will
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromu Ito |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of the Control for Rheumatic Diseases
Zip code
Address
54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
RA Center
Zip code
Address
TEL
075-751-3877
Homepage URL
Sponsor or person
Institute
RA Center, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2013 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011353
