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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022550
Receipt No. R000025515
Scientific Title Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair
Date of disclosure of the study information 2016/06/01
Last modified on 2016/05/31

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Basic information
Public title Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair
Acronym Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair
Scientific Title Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair
Scientific Title:Acronym Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living 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 examine the effect of walking training using walker with weight bearing lift on the recovery of activities of daily living 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 Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Standard rehabilitation program using walker with weight bearing lift. The estimated period of use: starting from an early stage after surgery to discharge from acute hospital(maximum), frequency: one time (10-20 minutes)). Rehabilitation program are generally based on clinical path adapted in each hospital. Lead principal investigator is not involved in minor change of program and clinical path.
Interventions/Control_2 Standard rehabilitation program. Conventional walker owned in the hospital is used in walking training. Rehabilitation program are generally based on clinical path adapted in each hospital. Lead principal investigator is not involved in minor change of program and clinical path.
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 50

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 06 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 Enrolling by invitation
Date of protocol fixation
2015 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 09 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 Recruitment is performed between September 2015 and March 2017. 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. The data of ADL level and nursing care level are collected by 1 year after surgery. In this study, the data of our observational study "Screening tool development for predicting the declines in activities of daily living and nursing care level after surgery for hip fracture repair" (UMIN000022216) are also used.

Management information
Registered date
2016 Year 05 Month 31 Day
Last modified on
2016 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025515

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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