UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009095 |
|---|---|
| Receipt number | 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 17:48:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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'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
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
t-nakanowatari@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010661
