UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057010 |
|---|---|
| Receipt number | R000065144 |
| Scientific Title | Evaluating the effects of visual stimulation on gait impairment in Parkinson's disease using an infrared depth-sensing camera |
| Date of disclosure of the study information | 2025/02/21 |
| Last modified on | 2025/05/26 14:22:56 |
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Basic information
Public title
Evaluating the effects of visual stimulation on gait impairment in Parkinson's disease using an infrared depth-sensing camera
Acronym
Evaluating the effects of visual stimulation on gait impairment in Parkinson's disease using an infrared depth-sensing camera
Scientific Title
Evaluating the effects of visual stimulation on gait impairment in Parkinson's disease using an infrared depth-sensing camera
Scientific Title:Acronym
Evaluating the effects of visual stimulation on gait impairment in Parkinson's disease using an infrared depth-sensing camera
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of visual stimulation on gait disturbance in Parkinson's disease patients using infrared depth-sensing camera and to establish appropriate and safe gait in a residential environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate changes in gait speed, stride length, step distance, foot height off the floor, arm swing angle, waist bend angle, and neck down angle with and without visual stimuli
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Gait analysis under three conditions: no visual stimulus, visual stimulus (height cm-100 cm), and visual stimulus (height cm-110 cm)
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. Parkinson's disease: Meet the diagnostic criteria of Japan Intractable Diseases Information Center
2. Patients who are able to walk longer than 10 meters if they are alone or under observation
3. Patients who give written consent to participate in this study
Key exclusion criteria
1. Patients with a history of intracranial disease and spinal cord disease other than the target disease
2. Patients judged inappropriate by the doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Fujita |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
371-8514
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-7111
yfujita@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Fujita |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
371-8514
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-7111
Homepage URL
yfujita@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Earth Care Co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15 Showa, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.jpu.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 | 02 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2030 | 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 | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065144
