UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055190 |
|---|---|
| Receipt number | R000063045 |
| Scientific Title | Effects and Safety of Optokinetic Stimulation Using a Head-Mounted Display on Motor Training for Stroke Patients |
| Date of disclosure of the study information | 2024/08/08 |
| Last modified on | 2024/08/07 16:59:21 |
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Basic information
Public title
Effects and Safety of Visual Stimulation Using a Head-Mounted Display on Motor Training for Stroke Patients
Acronym
Effects of Visual Stimulation Using a Head-Mounted Display on Motor Training for Stroke Patients
Scientific Title
Effects and Safety of Optokinetic Stimulation Using a Head-Mounted Display on Motor Training for Stroke Patients
Scientific Title:Acronym
Effects of Optokinetic Stimulation Using a Head-Mounted Display on Motor Training for Stroke Patients
Region
| Japan |
Condition
Condition
control, patients with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of optokinetic stimulation using a head-mounted display on the Motor Training of healthy individuals and stroke patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m walk test, EMG using electromyography, center of pressure, foot pressure
Key secondary outcomes
dizziness, Berg Balance Scale, Fugl-Meyer Assessment, functional independence measure
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Stroke patients or healthy individuals will be equipped with a head-mounted display and perform walking and sit-to-stand (squat) movements under optokinetic stimulation.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals and stroke hemiplegic patients admitted to the Kaifukuki Rehabilitation Hospital who meet the following conditions:
1)First seizure cerebral infarction or cerebral hemorrhage
2)More than 1 month to 6 months after onset
3)No obvious paralytic symptoms or motor deficits on the nonparalytic side
4)Walking or standing is supervised or independent.
Key exclusion criteria
1)Patients who are unable to understand the study description or cannot appeal for discontinuation of the study on their own in the event of abnormality.(For example mini mental state examination score: MMSE less than 21 points)
2)Patients under 18 years of age or over 85 years of age
3)Patients with severe sensory disturbance or marked muscle tone (modified Ashworth scale: MAS 3 or higher)
4)Patients who have difficulty understanding instructions due to the effects of attention disorders or other cognitive dysfunction
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Komagata |
Organization
Nagoya Women's University
Division name
Department of Physical Therapy
Zip code
467-8610
Address
3-40 Shioji-cho, Mizuho Ward, Nagoya, Aichi, Japan
TEL
052-852-1111
komagata@nagoya-wu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Komatsu |
Organization
Kamiina Seikyo Hospital
Division name
Department of Rehabilitation
Zip code
399-4601
Address
11324 Nakamino, Minowa Town, Kamiina District, Nagano, Japan
TEL
0265-79-8813
Homepage URL
sorapotiri@outlook.jp
Sponsor or person
Institute
Nagoya Women's University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kamiina Seikyo Hospital
Address
11324 Nakamino, Minowa Town, Kamiina District, Nagano, Japan
Tel
0265-79-8813
sorapotiri@outlook.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
| 2024 | Year | 08 | Month | 08 | 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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | 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
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063045
