UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044530 |
|---|---|
| Receipt number | R000050875 |
| Scientific Title | Verification of rehabilitation effect on activities of daily living (ADL) in bone metastasis |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2023/06/20 12:29:51 |
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Basic information
Public title
Verification of rehabilitation effect on activities of daily living (ADL) in bone metastasis
Acronym
EBMR
Scientific Title
Verification of rehabilitation effect on activities of daily living (ADL) in bone metastasis
Scientific Title:Acronym
EBMR
Region
| Japan |
Condition
Condition
Bone Metastasis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of rehabilitation on bone metastasis cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Background factors (age, gender, medical history, complications), metastatic site, PS, SINS, Milels score, Katagiri score, FIM, orthopedic consultation history will be obtained from medical records and investigated.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 7 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Bone metastasis cases of solid tumors undergoing rehabilitation from April 1, 2012 to March 31, 2019.
Key exclusion criteria
1) Double hospitalization
2) Cases in which the effect of rehabilitation cannot be determined due to death
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Maki |
| Middle name | |
| Last name | Itokazu |
Organization
Kndai Univercity Faculty Of Medicine
Division name
Department Of Rehabilitation
Zip code
589-8511
Address
377-2 Osakasayama-City
TEL
+81723668808
itokazumaki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Itokazu |
Organization
Kndai Univercity Faculty Of Medicine
Division name
Department Of Rehabilitation
Zip code
589-8511
Address
377-2 Osakasayama-City
TEL
+81723668808
Homepage URL
itokazumaki@yahoo.co.jp
Sponsor or person
Institute
Kndai Univercity Faculty Of Medicine
Institute
Department
Personal name
Funding Source
Organization
Non
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
Kndai Univercity Faculty Of Medicine Clinical Research Center
Address
377-2 Osakasayama-City
Tel
+81723668808
zizen@med.kindai.ac.jp
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
| 2021 | Year | 06 | Month | 21 | 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
92
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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Itokazu M, Higashimoto Y, Ueda M, Hanada K, Murakami S, Fukuda K. Effectiveness of Rehabilitation for Cancer Patients with Bone Metastasis. Prog Rehabil Med. 2022;7:20220027. Published 2022 May 18. doi:10.2490/prm.20220027
Management information
Registered date
| 2021 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050875
