UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051328 |
|---|---|
| Receipt number | R000058370 |
| Scientific Title | The immediate effect of real-time gait feedback by inertial measurement units on gait parameters (multicenter study) |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/06/13 11:07:30 |
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Basic information
Public title
The immediate effect of real-time gait feedback by inertial measurement units on gait parameters (multicenter study)
Acronym
The immediate effect of real-time gait feedback by inertial measurement units on gait parameters (multicenter study)
Scientific Title
The immediate effect of real-time gait feedback by inertial measurement units on gait parameters (multicenter study)
Scientific Title:Acronym
The immediate effect of real-time gait feedback on gait parameters
Region
| Japan |
Condition
Condition
stroke, orthopedic disease, sarcopenia
Classification by specialty
| Medicine in general | Neurology | Surgery in general |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clear the immediate effect of real time gait feedback by inertial measurement units (IMUs) for gait kinematics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gait speed
Key secondary outcomes
step length, cadence, joint angle during gait, physical function assessment
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control trial; usual gait traning. "walk at your usual pace during this trial"
Interventions/Control_2
Ankle trial; gait training with feedback for ankle joint motion by IMUs, "push back the ground harder before you swing your leg so that it makes a beep sound during this trial"
Interventions/Control_3
Leg trial; gait training with feedback for lower leg motion by IMUs, "extend your leg farther backward before you swing your leg so that it makes a beep sound during this trial"
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The ability to walk independently for at least 16m
2) Stable medical condition
3) Stroke, orthopedic disease, or sarcopenia
Key exclusion criteria
Hearing loss or cognitive problems that could impair the ability to understand experimental tasks.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takasuke |
| Middle name | |
| Last name | Miyazaki |
Organization
Kagoshima University
Division name
Department of Orthopaedic Surgery, Graduate School of Medical and Dental Sciences
Zip code
890-8520
Address
8-35-1, Sakuragaoka,Kagoshima
TEL
099-275-5381
k8345864@kadai.jp
Public contact
Name of contact person
| 1st name | Takasuke |
| Middle name | |
| Last name | Miyazaki |
Organization
Kagoshima University
Division name
Department of Orthopaedic Surgery, Graduate School of Medical and Dental Sciences
Zip code
890-8520
Address
8-35-1, Sakuragaoka,Kagoshima
TEL
099-275-5381
Homepage URL
k8345864@kadai.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Touhokufukushi university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University
Address
8-35-1, sakuragaoka, kagoshima
Tel
099-275-5111
k8345864@kadai.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 | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058370
| 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 |
