UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026077 |
|---|---|
| Receipt number | R000029801 |
| Scientific Title | The study of effective training method in early rehabilitation after knee arthroplasty: effects of quadriceps femoris muscle setting exercise with visual feedback |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2020/02/09 02:14:55 |
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Basic information
Public title
The study of effective training method in early rehabilitation after knee arthroplasty: effects of quadriceps femoris muscle setting exercise with visual feedback
Acronym
The study of effective training method in early rehabilitation after knee arthroplasty: effects of quadriceps femoris muscle setting exercise with visual feedback
Scientific Title
The study of effective training method in early rehabilitation after knee arthroplasty: effects of quadriceps femoris muscle setting exercise with visual feedback
Scientific Title:Acronym
The study of effective training method in early rehabilitation after knee arthroplasty: effects of quadriceps femoris muscle setting exercise with visual feedback
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 examine the effects of quadriceps femoris muscle setting exercise with visual feedback on physical function and QOL in early rehabilitation after knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
knee pain intensity at preoperation, 1, 2, and 3 week after operation
Key secondary outcomes
isometric knee extension strength
knee range of motion
timed up and go test
timed 10-meters walk test
6-min walk distance
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Hospital Anxiety and Depression Scale (HADS)
Pain Catastrophizing Scale (PCS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In addition to normal postoperative rehabilitation, quadriceps femoris muscle setting exercise using a leg dynamometer is carried out from the second day to the 14th day after operation.
Isometric contraction of the quadriceps femoris is maintained for 10 seconds at the intensity of 60% of maximum muscular strength. Exercise is performed 10 repetitions in one set, and it is performed 1 or 2 sets.
Interventions/Control_2
normal postoperative rehabilitation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent primary knee arthroplasty that is diagnosed osteoarthritis of the knee
Key exclusion criteria
1) patients who cannot walk alone
2) patients who greatly deviated from a clinical pass by complications after operation
3) patients with the orthopedic disease in lower limbs except the knee joint
4) patients with the neurologic finding including sensory disturbance and motor paralysis
5) patients with dementia and a mental disease
6) patients who do not agree to this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Kondo |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto Nagasaki, Japan
TEL
095-819-7919
yasukon48@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Kondo |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code
8528520
Address
1-7-1 Sakamoto Nagasaki, Japan
TEL
095-819-7919
Homepage URL
yasukon48@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamoto Nagasaki, Japan
Tel
095-819-7919
yasukon48@yahoo.co.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
日本赤十字社長崎原爆病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 10 | 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
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2020 | 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=R000029801
