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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027212
Receipt No. R000031175
Scientific Title The related factors of independent cane gait after total hip arthroplasty(THA)-Initiating cane gait training on the post operative day 1 decreases the days until cane gait independence after total hip arthroplasty-
Date of disclosure of the study information 2017/05/01
Last modified on 2018/02/19

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Basic information
Public title The related factors of independent cane gait after total hip arthroplasty(THA)-Initiating cane gait training on the post operative day 1 decreases the days until cane gait independence after total hip arthroplasty-
Acronym Initiating cane gait training on the post operative day 1 decreases the days until cane gait independence after total hip arthroplasty
Scientific Title The related factors of independent cane gait after total hip arthroplasty(THA)-Initiating cane gait training on the post operative day 1 decreases the days until cane gait independence after total hip arthroplasty-
Scientific Title:Acronym Initiating cane gait training on the post operative day 1 decreases the days until cane gait independence after total hip arthroplasty
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study was to compare the days until cane gait independence between patients initiating cane gait training on the post operative day 1 after THA with those training on the post operative day 2.
And we consider which training is effective after THA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes It is the possible or impossible of the cane gait independence on the post operative day 2 after THA.
Key secondary outcomes Patients demographics:
Age,sex,BMI,Affected side,surgical procedure,comorbidities,disease duration,preoperative physical function

Postoperative physical function:
Hip Range of motion,Hip abductor muscle strength,Single-limb stance time,Timed 10-meter walk test

Inflammation findings:
pain(rest,gait),C-reactive protein(CRP)

Imaging fingings:
Leg extention of intraoperative,Acetabular head index,Pelvic tilt angle



Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Initiating cane gait training on the post operative day 1 after THA
Interventions/Control_2 Initiating cane gait training on the post operative day 2 after THA
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Primary THA
2)The operative day is Monday or Wednesday
3)Age is above 50 years
4)Patients that an agreement was provided
Key exclusion criteria 1)Patients who were operated on revision surgery
2)Patients with severe orthopedic disease
3)Patients with progressive disoeder of the nervous system ond muscle
4)Patients scheduled for arthroplasy with osteotomy
5)Patinets scheduled for arthroplasy with hip adductor muscle dehiscence
6)Patients with dementia
7)Patients with the depression or schizophrenic disorder
8)Patients with cerebro-vascular disease
9)Patients with untreated cardio-vascular disorder
10)Others who judged that a researcher was inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Hirakawa
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Orthopedic
Zip code
Address 5-4-17 Dai,Kamakura,Kanagawa,Japan
TEL 0466-47-2377
Email mail@skjrc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunari Ninomiya
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Rehabilitation
Zip code
Address 5-4-17 Dai,Kamakura,Kanagawa,Japan
TEL 0466-47-2377
Homepage URL
Email mail@skjrc.jp

Sponsor
Institute Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization Shonan Kamakura Joint Reconstruction Center
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
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 医療法人沖縄徳洲会 湘南鎌倉人工関節センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 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 Completed
Date of protocol fixation
2017 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 08 Day
Last follow-up date
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 01 Day
Last modified on
2018 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031175

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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