UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024029 |
|---|---|
| Receipt number | R000027668 |
| Scientific Title | Effects of early starting of intensive functional rehabilitation on recovery of body function and activity in people undergoing total knee arthroplasty |
| Date of disclosure of the study information | 2016/09/14 |
| Last modified on | 2016/09/13 08:56:22 |
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Basic information
Public title
Effects of early starting of intensive functional rehabilitation on recovery of body function and activity in people undergoing total knee arthroplasty
Acronym
Trial of early starting of intensive functional rehabilitation in people undergoing total knee arthroplasty
(Early IFR trial)
Scientific Title
Effects of early starting of intensive functional rehabilitation on recovery of body function and activity in people undergoing total knee arthroplasty
Scientific Title:Acronym
Trial of early starting of intensive functional rehabilitation in people undergoing total knee arthroplasty
(Early IFR trial)
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the recovery of body function and activity between the people who start intensive functional rehabilitation (IFR) program within 2 weeks after surgery and the people who start IFR program since 2 weeks after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL(FIM or Barthel Index)/1, 2, 3, and 4 week after surgery
Key secondary outcomes
Pain (NRS), 30 second sit to stand test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
standard care and intensive functional rehabilitation program starting within 2 weeks after surgery
*intensive functional rehabilitation program
1. Get up and sit down
2. Knee extensor strengthening in standing with Theraband
3. Controlled bilateral knee flexion-extension in standing
4. Unilateral knee flexion to 90 in standing
5. Climbing on a platform or a flight of stairs
6. Walking laterally while crossing lower limbs
7. Walking in place, with large amplitude of hip and knee flexion and upper-limb movements
Interventions/Control_2
standard care and intensive functional rehabilitation program starting since 2 weeks after surgery
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) positive diagnosis of knee osteoarthritis
2) performed a total knee arthroplasty
3) inpatient
Key exclusion criteria
1) severe neurological disorder such as stroke
2) inhibited to intensive exercising by physician
3) positive diagnosis of dementia
4) positive diagnosis of articular rheumatism
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryo Tanaka |
Organization
Hiroshima International University
Division name
Department of Rehabilitation, Faculty of Rehabilitation
Zip code
Address
555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima
TEL
0823-70-4914
r-tanaka@hs.hirokoku-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Tanaka |
Organization
Hiroshima International University
Division name
Department of Rehabilitation, Faculty of Rehabilitation
Zip code
Address
555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima
TEL
0823-70-4914
Homepage URL
r-tanaka@hs.hirokoku-u.ac.jp
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima International University
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
中国労災病院（広島県）
広島赤十字・原爆病院（広島県）
広島市立安佐市民病院（広島県）
済生会呉病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 14 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 25 | 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
| 2016 | Year | 09 | Month | 13 | Day |
Last modified on
| 2016 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027668
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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