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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024029
Receipt No. 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

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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
Email 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
Email r-tanaka@hs.hirokoku-u.ac.jp

Sponsor
Institute Hiroshima International University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027668

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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