UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018872 |
|---|---|
| Receipt number | R000021817 |
| Scientific Title | The effect of walking training by using anti-gravity tredmil after total knee arthroplasty |
| Date of disclosure of the study information | 2015/09/05 |
| Last modified on | 2023/03/08 09:28:26 |
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Basic information
Public title
The effect of walking training by using anti-gravity tredmil after total knee arthroplasty
Acronym
The effect of anti-gravity tredmil after TKA
Scientific Title
The effect of walking training by using anti-gravity tredmil after total knee arthroplasty
Scientific Title:Acronym
The effect of anti-gravity tredmil after TKA
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of walking training by anti-gravity tredmil after total knee arthroplasty by using 3-dimentional walking evaluation system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
walking kinematics
(preoperation, p.o 2-3 weeks, p.o. 6-7 weeks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Walking training by using anti-gravity tredmil
30-60 minutes for each training
3 times (preoperation, p.o. 2-3 weeks, p.o. 6-7 weeks)
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1. Total knee arthroplasty will be performed for primary OA
2. Patient has given consent to participate in the study.
3. Rehabilitation will be able to start a week after operation.
4. less than 80 years old
Key exclusion criteria
1. Patient is immunosuppressed or has an autoimmune immunodeficient disorder.
2. Patient has an autoimmune disorder.
3. Patient has had major, non-arthroscopic surgery to the study knee.
4. Patient has an active, local infection or systemic infection.
5. Patient has a physical, emotional or neurological condition that would compromise compliance with postoperative rehabilitation and follow up.
6. Patient has pacemaker or possibility to have a trouble by using Bluetooth sensor.
7. Patient has hip inflammatory arthritis or performed THA.
8. Patient is pregnant or plans to pregnant during course of study.
9. Patient is on workman's compensation.
10. Serious medical infirmity.
11. Symptomatic spinal disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Harukazu |
| Middle name | |
| Last name | Tohyama |
Organization
Hokkaido University, Sapporo, Japan
Division name
Department of Rehabilitation
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-706-3393
tohyama@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Onodera |
Organization
Hokkaido University, Sapporo, Japan
Division name
Department of Orthopaedic Surgery
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-706-5935
Homepage URL
tomozou@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University, Sapporo, Japan
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University, Sapporo, Japan
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
Hokkaido University
Address
Kita 14, Nishi 5
Tel
0117065935
tomozou@med.hokudai.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
| 2015 | Year | 09 | Month | 05 | 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
| 2015 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021817
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
