UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030073 |
|---|---|
| Receipt number | R000034299 |
| Scientific Title | A study on a new rehabilitation program after total hip arthroplasty |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2017/11/22 08:24:49 |
* 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
A study on a new rehabilitation program after total hip arthroplasty
Acronym
Effect of early rehabilitation on total hip arthroplasty
Scientific Title
A study on a new rehabilitation program after total hip arthroplasty
Scientific Title:Acronym
Effect of early rehabilitation on total hip arthroplasty
Region
| Japan |
Condition
Condition
Patients after total hip arthroplasty
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect on outcome by rehabilitation program which starts rehabilitation immediately after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait analysis
Key secondary outcomes
Range of motion, muscle strength, pain, quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Rehabilitation (joint movement exercise, muscle strength exercise) is started within the possible range within 6 hours after total hip arthroplasty.
Interventions/Control_2
As usual, rehabilitation starts from the 2nd postoperative day.
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who undergoes primary total hip arthroplasty by hip osteoarthritis or femoral head necrosis.
Key exclusion criteria
Cases with motor and sensory disorders due to central nervous disorders, patients with mental illness, patients with dementia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Matsuo |
Organization
University of Fukui hospital
Division name
Division of Physical Therapy and Rehabilitation Medicine
Zip code
Address
23-3, Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8676
hideakim@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Matsuo |
Organization
University of Fukui Hospital
Division name
Division of Physical Therapy and Rehabilitation Medicine
Zip code
Address
23-3, Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8676
Homepage URL
hideakim@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui
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
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
| 2017 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
Management information
Registered date
| 2017 | Year | 11 | Month | 22 | Day |
Last modified on
| 2017 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034299
