UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052621 |
|---|---|
| Receipt number | R000059419 |
| Scientific Title | Effect of the kinesitherapy of the hand on outpatient rheumatoid arthritis |
| Date of disclosure of the study information | 2023/10/26 |
| Last modified on | 2024/03/21 11:09:24 |
* 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
Effect of the kinesitherapy of the hand on outpatient rheumatoid arthritis
Acronym
Effect of the kinesitherapy of the hand
Scientific Title
Effect of the kinesitherapy of the hand on outpatient rheumatoid arthritis
Scientific Title:Acronym
Effect of the kinesitherapy of the hand
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As for the rheumatoid arthritis, restraint of disease activity and the joint destruction continued coming to be provided by progress of the medical therapy, and the nonpharmacologic therapy is important to treatment, too. I carry in particular out kinesitherapy of the hand and, as the kinesitherapy that is one of the nonpharmacologic therapies, can expect usefulness as the evidence of the rheumatoid arthritis treatment choice by inspecting the effect and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change of Hand20 start of therapy and six months later
Key secondary outcomes
1) Hand20 start of therapy and three months later
2) Start of therapy and three months later, grip, Quick-DASH, HAK six months later, disease activity
3) Factor of the function improvement concerned
4) A safe evaluation: Harmful phenomenon
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
6 months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
I intend for a person meeting all the following standards
1) The rheumatoid arthritis patient who visits a hospital for treatment in the outpatient department
2) The patient that a walk becomes independent
3) The patients at the time of the agreement acquisition 20 years or older(I do not ask about the gender)
4) The study subject that a document agreement by the free will of the person was provided after having received enough explanation on participating of this study
Key exclusion criteria
It is decided that the person in conflict with any of the following does not incorporate it in this study
1) The patient who received an operation to put an artifact in the arms in the past
2) The patient who produces high joint destruction
3) In addition, the patient whom a manager for study judged to be inappropriate as a study subject
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Kamagaya General Hospital
Division name
Plastic surgery
Zip code
273-0121
Address
929-6, Hatsutomi, Kamagaya-shi, Chiba
TEL
047-498-8266
chiken@kamagaya-hp.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Kamagaya General Hospital
Division name
Plastic surgery
Zip code
273-0121
Address
929-6, Hatsutomi, Kamagaya-shi, Chiba
TEL
047-498-8266
Homepage URL
chiken@kamagaya-hp.jp
Sponsor or person
Institute
Kamagaya General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kamagaya General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushukai group combination ethic screening committee ethic
Address
1-3-1, Kudanminami, Chiyoda-ku, Tokyo Tokyo temple Chiyoda Building the 15th floor
Tel
03-3263-4801
mirai-ec4@mirai-iryo.com
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
| 2023 | Year | 10 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059419
