UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053887 |
|---|---|
| Receipt number | R000061514 |
| Scientific Title | Characteristics of lower limb muscle activity during walking and stair climbing with full weight bearing in postoperative ankle fracture patients |
| Date of disclosure of the study information | 2024/03/18 |
| Last modified on | 2024/03/18 14:47:25 |
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Basic information
Public title
Characteristics of lower limb muscle activity during walking and stair climbing with full weight bearing in postoperative ankle fracture patients
Acronym
Gait analysis using surface electromyography in patients with ankle fractures
Scientific Title
Characteristics of lower limb muscle activity during walking and stair climbing with full weight bearing in postoperative ankle fracture patients
Scientific Title:Acronym
Gait analysis using surface electromyography in patients with ankle fractures
Region
| Japan |
Condition
Condition
ankle fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Characterizing lower limb muscle activity during full weight-bearing walking in postoperative ankle fracture patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain (visual analog scale, VAS) and joint range of motion and lower limb muscle activity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Postoperative ankle fracture patients
Key exclusion criteria
The subjects were those who could not give consent to the purpose of the study and those who had severe motor paralysis due to stroke or other causes
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
masanobu@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
Homepage URL
masanobu@fmu.ac.jp
Sponsor or person
Institute
Takeda General Hospital
Institute
Department
Personal name
Masanobu Yokochi
Funding Source
Organization
Takeda General Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takeda General Hospital
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
Tel
0242275511
masanobu@fmu.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
| 2024 | Year | 03 | Month | 18 | 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
18
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
| 2021 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcome: lower limb muscle activity during walking and stair climbing by surface electromyography
Secondary outcome: Ankle joint range of motion, 10 m walking speed
After full weight bearing was allowed, the patient was able to walk unaided at a total of three points, one month and two months afterward.
The changes were measured at a total of three points, one and two months after the subject was able to walk unaided.
Management information
Registered date
| 2024 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061514
| 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 |
