UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050487 |
|---|---|
| Receipt number | R000057499 |
| Scientific Title | Development of prosthetic training using wearable gaze analyzer |
| Date of disclosure of the study information | 2023/03/04 |
| Last modified on | 2023/09/03 05:44:50 |
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Basic information
Public title
Development of prosthetic training using wearable gaze analyzer
Acronym
Development of prosthetic training using wearable gaze analyzer
Scientific Title
Development of prosthetic training using wearable gaze analyzer
Scientific Title:Acronym
Development of prosthetic training using wearable gaze analyzer
Region
| Japan |
Condition
Condition
Healthy adults, Upper limb amputation (Prosthesis users)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of eye guidance training, which adds the gaze behavior of a skilled prosthetic hand user during movement observation, on the control of prosthetic control, and to establish a new prosthetic control training program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gazing data (fixation time and frequency)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Study1. To elucidate eye gaze behavior during myoelectric and active prosthetic control using a wearable eye gaze analyzer.
Interventions/Control_2
Study2. To examine the effect of gaze guidance during Action observation on motor learning of prosthetic control.
Action observation of videos of healthy adult subjects with additional eye gaze behavior during control scenes of skilled prosthetic user and eye gaze guidance will be used to clarify the effect of eye gaze guidance on prosthetic control. The gaze behavior of the skilled prosthetic user will be created based on the gaze data analyzed in study1.
Sixty healthy adult subjects will be subjected to a comparative study under the following conditions.
Body powered prosthesis without gaze: (a group that observes prosthetic control video without the gaze behavior of the body-powered prosthetic expert)
Body powered prosthesis with gaze: (a group that observes a prosthetic control video with the gazing behavior of the body-powered prosthetic expert)
Body powered prosthesis, irrelevant video: (group that observes videos that are irrelevant to body-powered prosthetic control)
Myoelectric prosthesis without gaze: (a group that observes videos of prosthetic control without gaze behavior of a skilled myoelectric prosthetic user)
Myoelectric prosthesis with gaze: (a group that observes videos of prosthetic control with gazing behavior of a skilled myoelectric prosthetic user)
Myoelectric prosthesis, video with no eye movement: (group that observes videos of prosthetic operations unrelated to myoelectric prosthetic manipulation)
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Right handed healthy adults without neurological abnormalities, history of psychiatric disorders, or locomotor disorders.
Prosthetic users.
Key exclusion criteria
Subjects with a history of neurological abnormalities, psychiatric disorders, and musculoskeletal disorders. Subjects whose dominant hand is left-handed.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Yohimura |
Organization
Kawasaki Medical School Hospital
Division name
Rihabilitation center
Zip code
701-0192
Address
288 Matsushima, Kurashiki City, Okayama
TEL
0864621111
myoshimura@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Yohimura |
Organization
Kawasaki Medical School Hospital
Division name
Rehabilitation center
Zip code
701-0192
Address
288 Matsushima, Kurashiki City, Okayama
TEL
0864621111
Homepage URL
myoshimura@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School Hospital
Address
288 Matsushima, Kurashiki City, Okayama
Tel
0864621111
mnb328@med.kawasaki-m.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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 04 | 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
| 2023 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2023 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057499
