UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029045 |
|---|---|
| Receipt number | R000032974 |
| Scientific Title | Effect of exercise therapy with tibial internal-rotation on clinical outcomes and knee kinematics of osteoarthritis of the knee: a randomized controlled trial |
| Date of disclosure of the study information | 2017/09/29 |
| Last modified on | 2019/09/10 20:51:54 |
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Basic information
Public title
Effect of exercise therapy with tibial internal-rotation on clinical outcomes and knee kinematics of osteoarthritis of the knee: a randomized controlled trial
Acronym
Effect of exercise therapy with tibial internal-rotation
Scientific Title
Effect of exercise therapy with tibial internal-rotation on clinical outcomes and knee kinematics of osteoarthritis of the knee: a randomized controlled trial
Scientific Title:Acronym
Effect of exercise therapy with tibial internal-rotation
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of exercise with tibial internal-rotation on clinical outcomes and knee kinematics of osteoarthritis of the knee.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee joint kinematics before and after intervention (3 months)
Key secondary outcomes
Knee flexion/extension angle, Timed Up & Go Test, 20 m gait, WOMAC, SF-36, MRI, parameters of gait (three-dimensional analysis)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Novel knee exercise therapy with tibial internal-rotation was carried out for 3 months (once a week). Intervention was a manual therapy for improving range of tibial internal-rotation, and 3 exercises: tibial internal-external rotation, knee flexion/extension with tibial internal-rotation, knee-out squat. Participants carried out home-exercise every day.
Interventions/Control_2
Traditional knee exercise therapy was carried out for 3 months at a medical institution (once a week). Intervention was quadriceps muscle training, hip abduction, hip adduction, hip extension, leg press, squat. Participants carried out home-exercise every 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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females, 2) between 50 and 80 years old, 3) primary medial compartment knee osteoarthritis, 4) radiographic severity classified using Kellgren-Lawrence classification grade was grade I to grade III.
Key exclusion criteria
1) Lateral compartment knee osteoarthritis, 2) history of knee surgery, 3) receiving some kind of rehabilitation program, 4) subject who has a serious disease on knee joint, 5) history of rheumatoid arthritis, cerebropathy, neuropathy, gout, 6) risk of internal medicine, 7) mental disorder, 8) communication disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Gamada |
Organization
Hiroshima International University
Division name
Department of Rehabilitation
Zip code
739-2695
Address
555-36 Kurosegakuendai, Higashihiroshima City, Hiroshima
TEL
0823-70-4550
kazgamada@ortho-pt.com
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Kurose |
Organization
Hiroshima Prefectural Rehabilitation Center
Division name
Department of Orthopaedics
Zip code
739-0036
Address
295-3 Taguchi, Saijo-cho, Higashihiroshima City, Hiroshima
TEL
082-425-1455
Homepage URL
kurose0156@hiroshima-wsc.jp
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
Hiroshima International University
Address
555-36 Kurosegakuendai, Higashihiroshima City, Hiroshima
Tel
0823-70-4611
hu-gjmr1@ofc.hirokoku-u.ac.jp
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）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 07 | Day |
Last modified on
| 2019 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032974
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
