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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039402


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name