UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018872
Receipt No. 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 2017/03/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Harukazu Tohyama
Organization Hokkaido University, Sapporo, Japan
Division name Department of Rehabilitation
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo
TEL 011-706-3393
Email tohyama@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Onodera
Organization Hokkaido University, Sapporo, Japan
Division name Department of Orthopaedic Surgery
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo
TEL 011-706-5935
Homepage URL
Email tomozou@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University, Sapporo, Japan
Institute
Department

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
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

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 Open public recruiting
Date of protocol fixation
2015 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 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
2015 Year 09 Month 01 Day
Last modified on
2017 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021817

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.