UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034403
Receipt number R000039226
Scientific Title Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients
Date of disclosure of the study information 2018/11/01
Last modified on 2020/10/14 09:56:08

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Basic information

Public title

Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients

Acronym

Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients

Scientific Title

Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients

Scientific Title:Acronym

Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients

Region

Japan


Condition

Condition

Cerebral vascular disease, cervical spondylotic myelopathy

Classification by specialty

Neurology Orthopedics Neurosurgery
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to examine points to be improved and effects of the robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The favorable situation and the inappropriate situation that occurred based on specifications of the application (during the intervention with the application to the patients)

Key secondary outcomes

1)Unexpected malfunction of the application (during the intervention with the application to the patients)
2)questionnaire (after an intervention period)
3) Fugl-Meyer Assessment (before and after the intervention period)
4) Motor Activity Log (before and after the intervention period)
5) The amount of activity of the paralyzed upper limb (before and after the intervention period)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Robot application for upper limb rehabilitation (2 weeks. 20 minutes per once, once per 1 day, 5 days within 1 week)

Interventions/Control_2

Conventional rehabilitation (2 weeks. 20 minutes per once, once per 1 day, 5 days within 1 week)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inpatients at a convalescence rehabilitation ward in Kitasato University East Hospital who had an onset of cerebral vascular diseases or cervical spondylotic myelopathy before 1 month or earlier and have resulted upper limb motor paralysis

Key exclusion criteria

Inpatients who sustained upper limb motor paralysis before hospitalization or inpatients with cognitive dysfunction or higher brain dysfunction

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Naonobu
Middle name
Last name Takahira

Organization

School of Allied Health Sciences, Kitasato University

Division name

Physical Therapy Course, Department of Rehabilitation

Zip code

252-0373

Address

Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa

TEL

042-778-8111

Email

takahira@med.kitasato-u.ac.jp


Public contact

Name of contact person

1st name Naonobu
Middle name
Last name Takahira

Organization

School of Allied Health Sciences, Kitasato University

Division name

Physical Therapy Course, Department of Rehabilitation

Zip code

252-0373

Address

Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa

TEL

042-778-8111

Homepage URL


Email

takahira@med.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Industry Promotion Division, Industry Department, Industry and Labor Bureau, Kanagawa Prefectural Government

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

Shanti Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Kitasato Institute, Clinical Research Review Board

Address

Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa

Tel

042-778-8273

Email

rinrib@med.kitasato-u.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

北里大学東病院(神奈川県)/Kitasato University East Hospital (Kanagawa)


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 01 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

Completed

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB

2018 Year 11 Month 07 Day

Anticipated trial start date

2018 Year 11 Month 12 Day

Last follow-up date

2018 Year 12 Month 14 Day

Date of closure to data entry

2018 Year 12 Month 15 Day

Date trial data considered complete

2018 Year 12 Month 22 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 10 Month 08 Day

Last modified on

2020 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039226


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name