UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050279 |
|---|---|
| Receipt number | R000057252 |
| Scientific Title | Foam roller effect on total knee arthroplasty patients |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2023/02/09 04:49:02 |
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Basic information
Public title
Foam roller effect on total knee arthroplasty patients
Acronym
Effectiveness of physiotherapy with foam rollers
Scientific Title
Foam roller effect on total knee arthroplasty patients
Scientific Title:Acronym
Effectiveness of physiotherapy with foam rollers
Region
| Japan |
Condition
Condition
Patients after total knee arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a one-week foam roller intervention on patients after total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain (visual analog scale, VAS) and joint range of motion and walking ability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
foam roller(3 min) and Regular physical therapy(80min)
Interventions/Control_2
Regular physical therapy(80min)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients after total knee arthroplasty
Key exclusion criteria
Patients with rheumatoid arthritis and unstable surgical wounds
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
masanobu@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Nishi Kyushu University
Division name
Faculty of Rehabilitation Sciences
Zip code
842-8585
Address
4490-9 Ozaki, Kanzaki, Saga
TEL
0952524191
Homepage URL
nakamuramas@nisikyu-u.ac.jp
Sponsor or person
Institute
Takeda General Hospital
Institute
Department
Personal name
Masanobu Yokochi
Funding Source
Organization
Takeda General Hospital
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
Takeda General Hospital
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
Tel
0242275511
masanobu@fmu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 09 | 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
30
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
Terminated
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057252
