UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063354 |
|---|---|
| Receipt number | R000072511 |
| Scientific Title | Effects of rhythmic auditory stimulation on the temporal structure of gait variability and gait performance |
| Date of disclosure of the study information | 2026/10/21 |
| Last modified on | 2026/10/20 16:33:50 |
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Basic information
Public title
Effects of rhythmic auditory stimulation on gait variability and gait performance
Acronym
RAGV Study
Scientific Title
Effects of rhythmic auditory stimulation on the temporal structure of gait variability and gait performance
Scientific Title:Acronym
RAGV Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of four rhythmic auditory stimulation conditions (no cue, isochronous rhythm, random rhythm, and 1/f fluctuating rhythm) on the temporal structure of gait variability and gait performance in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
DFA scaling exponent (alpha) calculated from the stride-time time series during the 15-minute treadmill walking task
Key secondary outcomes
Stride-time coefficient of variation (CV) and Lyapunov exponent (LyE) during the 15-minute treadmill walking task. Maximum walking speed and the number of line deviations during the 15-cm-wide, 5-m walking task performed after treadmill walking.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants wear a right lower-limb orthosis throughout all walking tasks. After a 2-minute baseline walking assessment, participants walk on a treadmill for 15 minutes at an individually determined speed based on baseline walking data. No rhythmic auditory cue is provided in this group.
Interventions/Control_2
Participants wear a right lower-limb orthosis throughout all walking tasks. After a 2-minute baseline walking assessment, participants walk on a treadmill for 15 minutes while listening to an isochronous rhythmic auditory cue generated from baseline walking data. Participants are instructed to synchronize their steps with the cue as much as possible.
Interventions/Control_3
Participants wear a right lower-limb orthosis throughout all walking tasks. After a 2-minute baseline walking assessment, participants walk on a treadmill for 15 minutes while listening to a random rhythmic auditory cue generated from baseline walking data. Participants are instructed to synchronize their steps with the cue as much as possible.
Interventions/Control_4
Participants wear a right lower-limb orthosis throughout all walking tasks. After a 2-minute baseline walking assessment, participants walk on a treadmill for 15 minutes while listening to a rhythmic auditory cue with 1/f fluctuations generated from baseline walking data. Participants are instructed to synchronize their steps with the cue as much as possible.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults enrolled at Kawasaki University of Medical Welfare
Able to walk independently
Able to walk in synchronization with a rhythmic cue
Able to provide written informed consent after receiving an explanation of the study
Key exclusion criteria
History of neurological disease
Lower-limb orthopedic disease or pain
Dizziness or vestibular disorders
Visual or hearing impairment that may interfere with the walking tasks
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kimura |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Rehabilitation, Department of Physical Therapy
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama 701-0193, Japan
TEL
086-462-1111
kimura.d@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kimura |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Rehabilitation, Department of Physical Therapy
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama 701-0193, Japan
TEL
086-462-1111
Homepage URL
kimura.d@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukuoka Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kawasaki University of Medical Welfare
Address
288 Matsushima, Kurashiki, Okayama 701-0193, Japan
Tel
086-464-1010
kimura.d@mw.kawasaki-m.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
川崎医療福祉大学（岡山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 21 | 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 | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 20 | Day |
Last modified on
| 2026 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072511
