UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034600 |
|---|---|
| Receipt number | R000039402 |
| Scientific Title | Effect of action observation training on upper extremity performance and effective protocol of the training |
| Date of disclosure of the study information | 2018/10/25 |
| Last modified on | 2019/10/23 11:22:57 |
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Basic information
Public title
Effect of action observation training on upper extremity performance and effective protocol of the training
Acronym
Effect of action observation training on upper extremity performance and effective protocol of the training
Scientific Title
Effect of action observation training on upper extremity performance and effective protocol of the training
Scientific Title:Acronym
Effect of action observation training on upper extremity performance and effective protocol of the training
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To compare the effect of three training methods on upper extremity performance: Action observation for upper extremity task execution using videos (observation), only exercise, combination of observation and exercise for task.
2. To clarify the effective protocol for combination of observation and exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes: Time to complete upper extremity task
Measurement time: Before and after training
Key secondary outcomes
Outcomes: Questionnaire on the state of subjects at training
Measurement time: After training
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Program: To observe upper extremity task execution for 20 minutes.
Duration: 3 days
Frequency: once a day
Interventions/Control_2
Program: Observation for 10 minutes and exercise for 10 minutes, total 20 minutes.
Duration: 3 days
Frequency: once a day
Interventions/Control_3
Program: Observation for 2.5minutes and exercise for 2.5minute, total 5 minutes repeating 5 minutes approach 4 times.
Duration: 3 days
Frequency: once a day
Interventions/Control_4
Program: To perform exercises of upper extremity task for 20 minutes.
Duration: 3 days
Frequency: once a day
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Right handed
2. No previous experience of upper extremity task using in this study
Key exclusion criteria
Orthopedic disease, neurological disease, or psychiatric disease
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Sakaguchi |
Organization
Hyogo University of health sciences
Division name
Facalty of Rehabilitation
Zip code
6508530
Address
6-3-1 minatojima tyu-o-ku, kobe
TEL
078-304-3141
yu-sakaguchi@huhs.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Sakaguchi |
Organization
Hyogo University of health sciences
Division name
Facalty of Rehabilitation
Zip code
6508530
Address
6-3-1 minatojima tyu-o-ku, kobe
TEL
078-304-3141
Homepage URL
yu-sakaguchi@huhs.ac.jp
Sponsor or person
Institute
Hyogo University of health sciences
Institute
Department
Personal name
Funding Source
Organization
Hyogo University of health sciences
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
Hyogo University of health sciences
Address
6-3-1 minatojima tyu-o-ku, kobe
Tel
078-304-3141
yu-sakaguchi@huhs.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
| 2018 | Year | 10 | Month | 25 | 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
96
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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 22 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039402
