UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062118 |
|---|---|
| Receipt number | R000071085 |
| Scientific Title | A foundational study on dynamic stability evaluation of prosthetic and orthotic gait in clinical settings: validation of the maximum Lyapunov exponent using wearable sensors and short-segment data concatenation |
| Date of disclosure of the study information | 2026/07/03 |
| Last modified on | 2026/07/02 13:15:46 |
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Basic information
Public title
A foundational study evaluating dynamic stability of prosthetic gait using wearable sensors
Acronym
ProstheticGait-LyapStudy
Scientific Title
A foundational study on dynamic stability evaluation of prosthetic and orthotic gait in clinical settings: validation of the maximum Lyapunov exponent using wearable sensors and short-segment data concatenation
Scientific Title:Acronym
POGait-LyapValidation
Region
| Japan |
Condition
Condition
Healthy adult gait (no target disease). A non-therapeutic foundational study to validate methods for evaluating dynamic stability of prosthetic and orthotic gait.
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In healthy adults, mock prosthesis attachment and metronome-cued walking are performed, and gait data recorded with a pelvic wearable sensor smartphone are used to calculate the maximum finite-time Lyapunov exponent lambda max. The objectives are 1 to determine the minimum number of steps required for lambda max to reach a plateau 2 to validate whether lambda max from concatenated short walking segments can serve as a surrogate for lambda max from continuous walking using ICC and Bland-Altman analysis and 3 to examine the effects of free versus metronome-regulated walking and presence versus absence of mock prosthesis attachment on lambda max.
Basic objectives2
Others
Basic objectives -Others
To establish scientific evidence for wearable-sensor measurement protocols and data processing methods for prosthetic and orthotic gait evaluation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In healthy adults, mock prosthesis attachment and metronome-cued walking are performed, and gait data recorded with a pelvic wearable sensor (smartphone) are used to calculate the maximum finite-time Lyapunov exponent (lambda max). The objectives are: (1) to determine the minimum number of steps required for lambda max to reach a plateau; (2) to validate whether lambda max from concatenated short walking segments can serve as a surrogate for lambda max from continuous walking (ICC and Bland-Altman analysis); and (3) to examine the effects of free versus metronome-regulated walking and presence versus absence of mock prosthesis attachment on lambda max.
Key secondary outcomes
(1) Minimum number of steps for lambda max to reach a plateau (estimated by piecewise linear regression). (2) Agreement between lambda max from continuous walking and lambda max from concatenated short segments (ICC[2,1] and Bland-Altman analysis). (3) Differences in lambda max among four walking conditions (repeated-measures one-way ANOVA).
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Duration one visit per participant total about 90-120 minutes. Four within-subject conditions in sequence.
1 Free walking normal without mock prosthesis self-paced continuous about 300-400 steps and short segments.
2 Free walking with mock prosthesis on right lower limb self-paced continuous and short segments.
3 Regulated walking with mock prosthesis synchronized to individual metronome at conversational volume.
4 Regulated walking without mock prosthesis synchronized to same metronome.
Order of conditions 3 and 4 is randomized per participant.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults aged 18 years or older
2. Students graduate students or faculty and staff of Hokkaido University of Science
3. Able to understand the study in Japanese and provide voluntary consent
4. Able to walk safely on indoor level walkway and wear mock prosthesis safely
Key exclusion criteria
1. Neuromusculoskeletal disease balance disorder or severe visual or hearing impairment affecting gait
2. Pregnancy or self-reported possibility of pregnancy
3. Unable to wear mock prosthesis safely or with significant pain
4. Assessed by investigators as high fall risk
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kon |
Organization
Hokkaido University of Science
Division name
Department of Prosthetics and Orthotics Faculty of Health and Medical Sciences
Zip code
006-8585
Address
4-1-15 Maeda 7-jo Teine-ku Sapporo Hokkaido 006-8585 Japan
TEL
011-688-2240
kon@hus.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Kon |
Organization
Hokkaido University of Science
Division name
Hokkaido University of Science Faculty of Health and Medical Sciences
Zip code
0068585
Address
4-1,15tyou-me 7jyo maeda,teineku,sappro
TEL
0116882240
Homepage URL
kon@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science
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
Hokkaido University of Science Healthcare Ethics Committee
Address
4-1-15 Maeda 7-jo Teine-ku Sapporo Hokkaido 006-8585 Japan
Tel
011-688-2241
kenkyu@hus.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
| 2026 | Year | 07 | Month | 03 | 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
| 2026 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071085
