UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058943 |
|---|---|
| Receipt number | R000067378 |
| Scientific Title | Effects of Heel-Elevated Standing and Walking Training on Parkinson's Disease Patients: Motion Analysis Using Artificial Intelligence |
| Date of disclosure of the study information | 2025/09/09 |
| Last modified on | 2025/08/31 08:53:57 |
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Basic information
Public title
Effects of Heel-Elevated Standing and Walking Training on Parkinson's Disease Patients: Motion Analysis Using Artificial Intelligence
Acronym
Effects of Heel-Elevated Standing and Walking Training on Parkinson's Disease Patients: Motion Analysis Using Artificial Intelligence
Scientific Title
Effects of Heel-Elevated Standing and Walking Training on Parkinson's Disease Patients: Motion Analysis Using Artificial Intelligence
Scientific Title:Acronym
Effects of Heel-Elevated Standing and Walking Training on Parkinson's Disease Patients: Motion Analysis Using Artificial Intelligence
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will provide home exercise guidance to community-dwelling PD patients, utilizing heel lifts and visual cues for standing and walking practice aimed at improving gait. We will evaluate the effectiveness of this intervention. To assess changes in gait quality, we will record videos and analyze them using motion analysis software powered by artificial intelligence. Additionally, we will assess motor and cognitive function. This study aims to analyze the relationship between these assessment results and walking ability, investigating any characteristics or trends that emerge.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking ability (speed, stride length, joint angles, qualitative changes)
Evaluation Period: Before intervention, 2 weeks after intervention begins
Key secondary outcomes
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (hereinafter MDS UPDRS III), Mini Mental State Examination, New Freezing of Gait Questionnaire (hereinafter NFOG-Q), knee extension strength measured by handheld dynamometer, five-time sit-to-stand test, Time Up & Go test (hereinafter TUG), single-leg stance time, center of gravity sway test
Evaluation Period: Before intervention, 2 weeks after intervention begins
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
| Behavior,custom |
Interventions/Control_1
We provide indoor shoes with insoles to elevate the heel. Under these conditions, we instruct exercises that can be performed at home.
The exercise regimen consists of: 1. Chair stand-up practice (Guideline: 5-10 repetitions for 2-3 sets, at a slightly challenging intensity), 2. Step practice using visual cues (Guideline: 20 steps left and right for 2-3 sets, at a slightly challenging intensity), 3. Walking practice using visual cues (Guideline: 3-5 round trips for 2-3 sets, at a slightly challenging intensity).
Participants will perform these exercises for 2 weeks, after which effectiveness will be assessed.
For those who wish, carryover effects will be evaluated.
Participants will then resume their usual routine for 2 weeks, followed by a carryover effect assessment 2 weeks later.
If medication dosage changes cause a noticeable change in the participant's usual condition, participation in the study may be discontinued.
These exercises and evaluations are within the scope of standard medical care.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease patients capable of safe independent walking
Key exclusion criteria
Those unable to respond to the survey
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Matshshita |
Organization
Kochi Medical School, Kochi University
Division name
Department of Neurology
Zip code
783-0043
Address
185-1 Okochokohasu, Nankoku-shi, Kochi
TEL
088-888-2749
im71@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoharu |
| Middle name | |
| Last name | Nakayama |
Organization
Kochi Medical School, Kochi University
Division name
Department of Neurology
Zip code
783-0043
Address
185-1 Okochokohasu, Nankoku-shi, Kochi
TEL
088-888-2749
Homepage URL
im71@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Medical School, Kochi University
Address
185-1 Okochokohasu, Nankoku-shi, Kochi
Tel
088-880-2719
rinri21@kochi-u.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 | 09 | Month | 09 | 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 | 08 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067378
