UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058683 |
|---|---|
| Receipt number | R000067101 |
| Scientific Title | The effect of electric ankle support using a walking aid device on knee joint movement during the standing phase after TKA surgery |
| Date of disclosure of the study information | 2025/08/04 |
| Last modified on | 2025/08/03 21:47:04 |
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Basic information
Public title
The effect of robotic ankle electric assistance on knee joint movement during the standing phase after total knee arthroplasty
Acronym
The effect of ankle electric assistance on knee joint movement after total knee arthroplasty
Scientific Title
The effect of electric ankle support using a walking aid device on knee joint movement during the standing phase after TKA surgery
Scientific Title:Acronym
The effect of ankle electric assistance on knee joint movement after TKA surgery
Region
| Japan |
Condition
Condition
Post-TKA patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of electric ankle support using a walking aid device on knee joint movement during the stance phase after TKA surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee extension angle during stance phase(change in knee extension angle before and after stepping)
Key secondary outcomes
Lower limb joint movement (ankle joint angle during and before/after exercise, and knee joint angle during exercise), pain, knee joint range of motion, knee joint extension strength, walking speed, Time and Up Go Test, basic information (age, gender, BMI, number of days after surgery at the time of measurement)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Lower limb flexion and extension movement with walking aid ON
Washout
Lower limb flexion and extension movement with walking aid OFF
Interventions/Control_2
Lower limb flexion and extension movement with walking aid OFF
Washout
Lower limb flexion and extension movement with walking aid ON
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
Those who have undergone artificial knee replacement surgery at our hospital and have been prescribed physical therapy
Those with restricted knee extension while standing
Those with normal ADL prior to injury and a J or A level of independence in daily living for elderly people with disabilities
Those without dementia and a level of independence in daily living for elderly people with dementia of 1 or 2
Those who were able to walk independently or with a cane prior to surgery
Key exclusion criteria
Those with a history of cerebrovascular disease, degenerative disease, or other diseases that affect lower limb function
Those whose discharge was delayed due to postoperative complications or weight-bearing restrictions
Those who did not consent to participate in the study
Those for whom continuous evaluation and measurement was difficult
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | satoshi |
| Middle name | |
| Last name | uchida |
Organization
chugoku roisai hospital
Division name
central rehabilitation department
Zip code
737-0193
Address
1-5-1 Hirotaga, Kure City, Hiroshima
TEL
0823-72-7171
ireha@chugokuh.johas.go.jp
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | uchida |
Organization
chugoku roisai hospital
Division name
central rehabilitation department
Zip code
737-0193
Address
1-5-1 Hirotaga, Kure City, Hiroshima
TEL
0823-72-7171
Homepage URL
ireha@chugokuh.johas.go.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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
chugoku roisai hospital
Address
1-5-1 Hirotaga, Kure City, Hiroshima
Tel
0823-72-7171
ireha@chugokuh.johas.go.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
| 2025 | Year | 08 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 08 | Month | 03 | Day |
Last modified on
| 2025 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067101
