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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009095
Receipt No. R000010661
Scientific Title Effectiveness of therapeutic exercises or a shoe lift for functional leg length discrepancy after total hip arthroplasty
Date of disclosure of the study information 2012/10/12
Last modified on 2017/11/27

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Basic information
Public title Effectiveness of therapeutic exercises or a shoe lift for functional leg length discrepancy after total hip arthroplasty
Acronym Intervention study for functional leg length discrepancy after THA
Scientific Title Effectiveness of therapeutic exercises or a shoe lift for functional leg length discrepancy after total hip arthroplasty
Scientific Title:Acronym Intervention study for functional leg length discrepancy after THA
Region
Japan

Condition
Condition total hip arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effectiveness of therapeutic exercises or a shoe lift in improving functional and perceived leg length discrepancy and functional outcomes in patients after THA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional and perceived leg length discrepancy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 therapeutic exercise 2 weeks
Interventions/Control_2 shoe lift 2 weeks
Interventions/Control_3 a standard rehabilitation
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
85 years-old >=
Gender Male and Female
Key inclusion criteria inpatients after elective THA
unilateral and primary arthroplasty
functional leg length discrepancy more than 5 mm
having patient-perceived leg length discrepancy
weight less than 100 kg
ASA up to 3
possible communication
consent of patient
Key exclusion criteria anamnesis of central or peripheral disorder
operation time more than 3 hours
osteotomy
grafted bone
serious complication
inappropriate by their doctor&#39;s judgement
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Izumi
Organization Tohoku University graduate school of biomedical engineering
Division name Physical medicine and Rehabilitation
Zip code
Address 2-1 Seiryo-machi, Aobaku, Sendai
TEL 022-717-7338
Email t-nakanowatari@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Nakanowatari
Organization Yamagata Prefectural Univercity of Health Sciences
Division name Physical Therapy
Zip code
Address 260 Kamiyanagi, Yamagata city, Yamagata
TEL 023-686-6665
Homepage URL
Email t-nakanowatari@med.tohoku.ac.jp

Sponsor
Institute Tohoku University graduate school of medicine
Institute
Department

Funding Source
Organization administrative cost of department
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
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 松田病院(宮城県)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.physiotherapyjournal.com/issue/S0031-9406(15)X0004-6?page=27
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
2012 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2014 Year 02 Month 28 Day
Date of closure to data entry
2014 Year 04 Month 30 Day
Date trial data considered complete
2014 Year 06 Month 30 Day
Date analysis concluded
2016 Year 11 Month 09 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 11 Day
Last modified on
2017 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010661

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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