UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059768 |
|---|---|
| Receipt number | R000068346 |
| Scientific Title | Examining the immediate effects of timing-specific plantar vibration stimulation during the gait cycle in Parkinson's disease |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 17:00:05 |
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Basic information
Public title
Examining the immediate effects of timing-specific plantar vibration stimulation during the gait cycle in Parkinson's disease
Acronym
Plantar vibration stimulation for gait impairments in Parkinson's disease
Scientific Title
Examining the immediate effects of timing-specific plantar vibration stimulation during the gait cycle in Parkinson's disease
Scientific Title:Acronym
Timing-specific plantar vibration study in Parkinson's disease (TS-PV-PD study)
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how the timing of plantar vibration stimulation within the gait cycle affects gait performance in clinical settings among individuals with Parkinson's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II,III
Assessment
Primary outcomes
Gait velocity
Step length
Key secondary outcomes
Cadence
Swing time/Stance time
Duration of Double limb support
Stride time variability
Variability and asymmetry of step time and step length
Freezing ratio
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Plantar vibration at initial contact
Interventions/Control_2
Plantar vibration at heel-off
Interventions/Control_3
No stimulation
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Hoehn & Yahr stage 1-4
2)Able to walk over 20 meters without assistance
Key exclusion criteria
1)Commorbid neurological dseases other than Parkinson's disease
2)Cognitive impairments(Mini-Mental State Examination less than 24)
3)Sensory Disturbances or pain in both lower limbs
4)Unstable medication state due to inadequate adjustment of antiparkinsonian medication
5)Dyskinesia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | Unicersityand Yohei |
| Last name | Okada |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
6350832
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
y.okada@kio.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Okada |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
6350832
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
Homepage URL
y.okada@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Tsubakimoto Chain Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University Research Ethics Committee
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
Tel
+81-745-54-1601
soumu@kio.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
| 2025 | Year | 11 | Month | 13 | 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
| 2025 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068346
