UMIN-CTR Clinical Trial

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
Email	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
Email	yu-sakaguchi@huhs.ac.jp

Sponsor
Institute	Hyogo University of health sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039402