UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024196 |
|---|---|
| Receipt number | R000027856 |
| Scientific Title | The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2016/09/28 |
| Last modified on | 2017/11/12 18:33:00 |
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Basic information
Public title
The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial
Acronym
Effects of preoperative rehabilitation program on outcomes after TKA
Scientific Title
The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial
Scientific Title:Acronym
Effects of preoperative rehabilitation program on outcomes after TKA
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of preoperative exercise with tibial internal rotation on improving knee kinematics and clinical outcomes after total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee joint kinematics
Key secondary outcomes
Knee flexion angle, WOMAC, SF-36
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Novel knee rehabilitation (3 months) (tibial internal-external rotation with knee bending, Leg flexion/extension with tibial internal-rotation, knee-out squat
Interventions/Control_2
Traditional knee rehabilitation(3 months)
(quad setting, active straight leg raising, hip abduction, hip lift)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) Japanese males and females, (b) between 50 and 80 years old, (c) primary medial compartment knee osteoarthritis, (d) radiographic severity classified using Kellgren-Lawrence System was grade III to grade IV.
Key exclusion criteria
(a) lateral compartment knee osteoarthritis, (b) history of knee surgery, (c) receiving some kind of rehabilitation program, (d) subject who has a serious disease on knee joint, (e) history of rheumatoid arthritis, cerebropathy, neuropathy, gout.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Gamada |
Organization
Graduate School of Hiroshima International University
Division name
Medical Technology and Health Welfare Sciences
Zip code
Address
555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima
TEL
0823-70-4550
kazgamada@ortho-pt.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Hoshi |
Organization
Graduate School of Hiroshima International University
Division name
Medical Technology and Health Welfare Sciences
Zip code
Address
555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima
TEL
0823-70-4550
Homepage URL
pt.hoshiken@gmail.com
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroshima Prefectural Rehabilitation Center
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
広島県立障害者リハビリテーションセンター（広島県）/広島県立障害者リハビリテーションセンター（広島県） / Hiroshima Prefectural Rehabilitation center（Hiroshima）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 27 | Day |
Last modified on
| 2017 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027856
