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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022216
Receipt No. R000025513
Scientific Title Screening tool development for predicting the declines in activities of daily living and nursing care level after surgery for hip fracture repair
Date of disclosure of the study information 2016/05/09
Last modified on 2017/05/16

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Basic information
Public title Screening tool development for predicting the declines in activities of daily living and nursing care level after surgery for hip fracture repair
Acronym Screening tool development for predicting the declines in activities of daily living and nursing care level after surgery for hip fracture repair
Scientific Title Screening tool development for predicting the declines in activities of daily living and nursing care level after surgery for hip fracture repair
Scientific Title:Acronym Screening tool development for predicting the declines in activities of daily living and nursing care level after surgery for hip fracture repair
Region
Japan

Condition
Condition Hip Fracture
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop and assess screening tools to predict the declines in activities of daily living and nursing care level after surgery for hip fracture repair.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ADL (Barthel Index): at 2 weeks, 6 months, 9 months, and 1 year after surgery
Key secondary outcomes nursing care level: at 1 year after surgery

Base
Study type Observational

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)fractured the proximal part of their femur
2)underwent a surgery, such as a femoral head replacement
3)degree of independent daily living for the disabled elderly of J or A
4)independent daily living score for the demented elderly of 1 or 2
Key exclusion criteria 1)the existence of hip fracture on the opposite side
2)multiple fractures
3)no permit for weight bearing immediately after surgery
4)pathological fracture
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Tanaka
Organization Hiroshima International University
Division name Department of Rehabilitation, Faculty of Rehabilitation
Zip code
Address 555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima
TEL 0823-70-4914
Email r-tanaka@hs.hirokoku-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Tanaka
Organization Hiroshima International University
Division name Department of Rehabilitation, Faculty of Rehabilitation
Zip code
Address 555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima
TEL 0823-70-4914
Homepage URL
Email r-tanaka@hs.hirokoku-u.ac.jp

Sponsor
Institute Hiroshima International University
Institute
Department

Funding Source
Organization MHLW(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 05 Month 09 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 Completed
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a cohort study. Recruitment is performed between June 2013 and June 2015. Patients are selected only who provide written informed consent. Measurement items include pre-rehabilitation baseline data (age, sex, gait method, place of residence, ADL level, nursing care level, type of fracture, and surgical method). ADL disabilities, Chair-stand-30 (CS-30) test results, and pain intensity at 2 weeks after surgery are also included.This study examines the relationship between functional ability in hospital and the declines in activities of daily living and nurse care level after surgery. The data obtained from this study will be used in another interventional study (Official scientific title of the study: Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair)

Management information
Registered date
2016 Year 05 Month 06 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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