UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058325 |
|---|---|
| Receipt number | R000066445 |
| Scientific Title | Investigation of the effectiveness of an upper limb functional training program using Virtual Reality technology for patients with Parkinson's disease |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/30 20:50:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the effectiveness of an upper limb functional training program using Virtual Reality technology for patients with Parkinson's disease
Acronym
Efficacy of Virtual Reality for the Upper Extremity in Patients with Parkinson's Disease
Scientific Title
Investigation of the effectiveness of an upper limb functional training program using Virtual Reality technology for patients with Parkinson's disease
Scientific Title:Acronym
Efficacy of Virtual Reality for the Upper Extremity 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
Prospectively test the effectiveness of an upper limb functional training program using VR technology in Parkinson's disease patients with upper limb dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Box and Block Test
Evaluations will be conducted at the beginning of the study, 2 months after the start of the study, and 5 months after the start of the study
Key secondary outcomes
Basic Information
Age,gender,name of primary disease,and dose of antiparkinsonism medication
Physical and cognitive function assessment
Disease severity:Hoehn-Yahr Stage
Cognitive Function Test Assessment:The Montreal Cognitive Assessment Japanese version
Unified Parkinson's Disease Rating Scale
Upper Limb Functional Assessment:Nine hole peg Test
Depression Assessment:Geriatric depression Scale15
Balanced Evaluation:The Mini-Balance Evaluation Systems Test
Grip strength
Measurement of muscle mass using the Inbody body
Effectiveness determination in goal-setting:Goal Attainment Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention period is 8 weeks.Frequency of intervention is twice a week.Training time is 60 minutes per session.Forty minutes will be used for regular practice, by 20 minutes of Virtual Reality intervention.
Interventions/Control_2
Intervention period is 8 weeks.Frequency of intervention is twice a week.Training time is 60 minutes per session.Forty minutes of the exercise should be normal practice,and 20 minutes should be upper limb exercises without Virtual Reality.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Able to come to outpatient rehabilitation twice a week for one hour per visit.
Those whose Hoehn-Yahr severity classification is Stage III or lower
Persons who have given written consent to participate in this study
Key exclusion criteria
above the cut-off value in the screening for Virtual Reality sickness.
inner ear disorders who are prone to Virtual Reality sickness
Those who have difficulty continuing to use VR for more than 10 minutes due to Virtual Reality sickness during the Virtual Reality experience conducted beforehand.
Patients receiving Levodopa-carbidopa intestinal gel therapy or Deep Brain Stimulation
vision impairment significant enough to affect the intervention
diagnosed with other neurological diseases or dementia.
Persons with limited range of motion of the upper limb that makes it difficult to perform Virtual Reality.
Other persons deemed unfit by the physician.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Higashi |
Organization
Nagasaki University
Division name
Department of Life and Medical Sciences (Health Sciences)
Zip code
852-8102
Address
1-12-4 Sakamoto, Nagasaki-shi, Nagasaki-ken 852-8102 Japan
TEL
+81-819-7900
higashi-t@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kodai |
| Middle name | |
| Last name | Yamaguchi |
Organization
Nagasaki Kita Hospital
Division name
Deparetment of Rehabilitation
Zip code
851-2103
Address
800 Motomurago,Tokitsu-cho,Nishisonogi-gun,Nagasaki 851-2103,Japan
TEL
+81-866-8700
Homepage URL
y.m.g.ch.ko@gmail.com
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Kodai Yamaguchi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Kita Hospital
Address
800 Motomurago,Tokitsu-cho,Nishisonogi-gun,Nagasaki 851-2103,Japan
Tel
+81-866-8700
y.m.g.ch.ko@gmail.com
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
長崎北病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | 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 | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066445
