UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056663 |
|---|---|
| Receipt number | R000064765 |
| Scientific Title | Estimation of abnormal movement during upper limb movements using a head-mounted display in patients with cerebrovascular disease: a reliability, validity, and feasibility study |
| Date of disclosure of the study information | 2025/01/08 |
| Last modified on | 2025/01/08 12:35:58 |
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Basic information
Public title
Estimation of abnormal movement during upper limb movements using a head-mounted display in patients with cerebrovascular disease: a reliability, validity, and feasibility study
Acronym
Estimation of abnormal movement during upper limb movements using a head-mounted display in patients with cerebrovascular disease
Scientific Title
Estimation of abnormal movement during upper limb movements using a head-mounted display in patients with cerebrovascular disease: a reliability, validity, and feasibility study
Scientific Title:Acronym
Estimation of abnormal movement during upper limb movements using a head-mounted display in patients with cerebrovascular disease
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the reliability and validity of detecting abnormal movements during upper limb elevation with a head-mounted display (HMD) and the feasibility of establishing an upper limb exercise task based on abnormal movements acquired with the HMD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abnormal movements were calculated using HMD and motion capture.
Satisfaction surveys: Quebec User Evaluation of Satisfaction Scale (QUEST 2.0) and System Usability Scale (SUS).
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A reaching task is performed with the HMD, in which the movement range is defined based on the abnormal movement.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 18 years and older.
2. Those who have a history of cerebrovascular disease.
3. More than 90 days after the onset of cerebrovascular disease.
Key exclusion criteria
1. Those who have upper limb diseases other than central motor paralysis due to cerebrovascular diseases (e.g., fracture of the upper limb).
2. Those who have difficulty communicating due to aphasia or impaired consciousness.
3. Those with difficulty performing evaluations due to severe higher brain dysfunction.
4. Those who have severe visual or hearing impairment.
5. Those with severe psychiatric disorders such as depression or schizophrenia.
6. Contraindications to exercise therapy.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
1608582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
1608582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
Homepage URL
daisuke.ito@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Daisuke Ito
Funding Source
Organization
New Energy and Industrial Technology Development Organization
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
Keio University
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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 | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | 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
| 2025 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064765
