UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051623 |
|---|---|
| Receipt number | R000058826 |
| Scientific Title | Influence of arm swing movement using wearable robot in sitting position on gait of total knee arthroplasty patients |
| Date of disclosure of the study information | 2023/07/16 |
| Last modified on | 2023/08/08 08:40:47 |
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Basic information
Public title
Influence of arm swing movement using wearable robot in sitting position on gait of total knee arthroplasty patients
Acronym
Influence of arm swing movement using wearable robot in sitting position on gait of total knee arthroplasty patients
Scientific Title
Influence of arm swing movement using wearable robot in sitting position on gait of total knee arthroplasty patients
Scientific Title:Acronym
Influence of arm swing movement using wearable robot in sitting position on gait of TKA patients
Region
| Japan |
Condition
Condition
Patients underwent knee arthroplasty for knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether arm swinging with a robot in a sitting position affects walking in patients underwent knee arthroplasty,
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking indicators measured by wearable sensors attached to the legs and hips.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants wear wearable robots and wave their arms in rhythm with the robot for a few minutes. The robot uses an encoder to measure the angle of arm swing between the left and right sides of a person. The angle information is converted into phase information by the microcomputer mounted on the robot. The phase is 0 for the moment when the left arm is swung back, and the moment when the right arm is swung back is . Based on the phase data, the stimulus is presented by a frame moved by a motor. Specifically, when the participant swings his arm backwards, somatosensory stimulation is presented backwards to the upper arm. The force at this time is about 500 g heavy.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent TKA for knee osteoarthritis
Key exclusion criteria
Patients with severe postoperative complications, those who cannot walk with a single cane or walk alone, those with upper limb paralysis or dysfunction, and those with cognitive decline.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358034020
ynakagawa.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Shirahata |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358034020
Homepage URL
shirahata.orj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical and Dental University Hospital of Medicine
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035096
info.bec@tmd.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
| 2023 | Year | 07 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058826
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
