UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058433 |
|---|---|
| Receipt number | R000066800 |
| Scientific Title | Investigation of Responses to Sensory Stimuli for Gait Improvement in Patients with Parkinson's Disease |
| Date of disclosure of the study information | 2025/07/11 |
| Last modified on | 2025/07/11 15:15:56 |
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Basic information
Public title
Investigation of Responses to Sensory Stimuli for Gait Improvement in Patients with Parkinson's Disease
Acronym
Investigation of Responses to Sensory Stimuli for Gait Improvement in Patients with Parkinson's Disease
Scientific Title
Investigation of Responses to Sensory Stimuli for Gait Improvement in Patients with Parkinson's Disease
Scientific Title:Acronym
Investigation of Responses to Sensory Stimuli for Gait Improvement in Patients with Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of sensory stimulation, based on gait data measured by smart shoes, on gait disturbances in patients with Parkinson's disease (PD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait-related parameters obtained from inertial measurement units (IMUs).
Key secondary outcomes
Fear or anxiety during walking, Timed Up and Go Test (TUGT), 10-meter Walk Test (10MWT), Figure-8 Walk Test, and 2-Minute Walk Test (2MWT)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Sensory Stimuli(Auditory stimulation using a music feedback system,Somatosensory stimulation using a pneumatic artificial muscle system.)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Diagnosed with Parkinson's disease or related disorders.
2)Aged 20 years or older at the time of obtaining consent.
Key exclusion criteria
1)Patients who are unable to walk and require a wheelchair at all times.
2)Patients diagnosed with severe osteoporosis or with a history of multiple fractures, who may have a high risk of bone fracture in case of a fall during the experiment.
3)Patients diagnosed with severe heart disease.
4)Patients who are unable to understand the study explanation.
5)Patients deemed inappropriate for participation by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Sawada |
Organization
Reiwa Health Sciences University
Division name
School of Physical Therapy, Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-607-6701
m.sawada@kyoju.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Sawada |
Organization
Reiwa Health Sciences University
Division name
School of Physical Therapy, Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-607-6701
Homepage URL
m.sawada@kyoju.ac.jp
Sponsor or person
Institute
Reiwa Health Sciences University
Institute
Department
Personal name
Makoto Sawada
Funding Source
Organization
New Energy and Industrial Technology Development Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reiwa Health Sciences University
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
Tel
092-607-6701
m.sawada@kyoju.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
福岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 11 | 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 | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 14 | 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
| 2025 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066800
