UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027130
Receipt number R000031086
Scientific Title Development of new upper limb function test method using three-dimensional motion analysis system
Date of disclosure of the study information 2017/04/25
Last modified on 2021/12/01 19:29:39

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Basic information

Public title

Development of new upper limb function test method using three-dimensional motion analysis system

Acronym

Development of new upper limb function test method using three-dimensional motion analysis system

Scientific Title

Development of new upper limb function test method using three-dimensional motion analysis system

Scientific Title:Acronym

Development of new upper limb function test method using three-dimensional motion analysis system

Region

Japan


Condition

Condition

Healthy subjects,Upper limb dysfunction

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish indices to evaluate upper limb functions which are closely related the frequent movement patterns in daily life using the three-dimensional motion analysis system.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Displacement, speed and acceleration of markers placed on upper limb joints and trunk.

Key secondary outcomes

Stroke Impairment Assessment Set (SIAS),Fugl-Meyer Assessment Scale (FMA),Functional Independence Measure (FIM)


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

Prevention

Type of intervention

Maneuver

Interventions/Control_1

To instruct the participants to perform the upper limb movement task and track the movements of markers placed on the upper limb and finger joints.

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) healthy subjects
Persons aged 16 years or older with informed consent to participate the research, who had no history of upper limb dysfunction due to diseases such as stroke, neuromuscular diseases, musculoskeletal diseases.
2) upper limb dysfunction
Physically stable patients aged 16 years or older with informed consent to participate the research, who suffers from upper limb dysfunction.

Key exclusion criteria

Those who have difficulty in maintaining a sitting position for 30 minutes.
Those who have difficulty to follow instructions because of consciousness disorder/ cognitive disorder.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yohei
Middle name
Last name Otaka

Organization

Fujita Health University

Division name

Department of Rehabilitation Medicine I,school of Medicine

Zip code

470-1192

Address

1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan

TEL

0562-93-2167

Email

rehabmed@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Hirofumi
Middle name
Last name Ota

Organization

Fujita Health University

Division name

Faculty of Rehabilitation, School of Health Sciences

Zip code

470-1192

Address

1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan

TEL

0562-93-9000

Homepage URL


Email

hiro0527@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Fujita Health University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Research IRB, Center for research promotion and support, Fujita Health University

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan

Tel

0562-93-2865

Email

f-irb@fujita-hu.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

2017 Year 04 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


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

Enrolling by invitation

Date of protocol fixation

2016 Year 12 Month 08 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 04 Month 25 Day

Last modified on

2021 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name