UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045460
Receipt number R000051905
Scientific Title The Characteristics and intervention effects of Adjustability of Grasping Force in Patients With Cerebrovascular Disorder -Examination using a quantitative Adjustability of Grasping Force measuring device (iWakka)-
Date of disclosure of the study information 2021/09/16
Last modified on 2023/03/16 09:26:26

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Basic information

Public title

The Characteristics and intervention effects of Adjustability of Grasping Force in Patients With Cerebrovascular Disorder -Examination using a quantitative Adjustability of Grasping Force measuring device (iWakka)-

Acronym

The Characteristics and intervention effects of Adjustability of Grasping Force in Patients With Cerebrovascular Disorder -Examination using a quantitative Adjustability of Grasping Force measuring device (iWakka)-

Scientific Title

The Characteristics and intervention effects of Adjustability of Grasping Force in Patients With Cerebrovascular Disorder -Examination using a quantitative Adjustability of Grasping Force measuring device (iWakka)-

Scientific Title:Acronym

The Characteristics and intervention effects of Adjustability of Grasping Force in Patients With Cerebrovascular Disorder -Examination using a quantitative Adjustability of Grasping Force measuring device (iWakka)-

Region

Japan


Condition

Condition

Patients with cerebrovascular disorder

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the characteristics of the Adjustability of Grasping Force of stroke patients and to examine the intervention effect on the gripping ability adjusting ability.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

iWakka

Key secondary outcomes

FIM
Grip strength
Action Research Arm Test(ARAT)
Fugl-Meyer Assessment(FMA)
Simple Test for Evaluating Hand Function(STEF)
Motor Activity Log(MAL)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

Adjustability of Grasping Force training using iWakka(5 times a week, about 1 hour each time, intervention period is 2 weeks)

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Understand oral instructions
2) No pain in fingers
3) Brunnstrom recovery stage 4 and above
4) The wrist joint on the paralyzed side can be extended by 20 or more at will.
5) The IP and MP joints of the paralyzed side 1 to 3 fingers can be extended by 10 or more.
6) The sitting position is stable

Key exclusion criteria

1) Have experience of performing similar tasks in the past
2) Have a current or history of orthopedic or neurological disorders of the fingers that may interfere with life on the non-paralyzed side
3) Significant aphasia, attention disorder, hemilateral visual space neglect, cognitive dysfunction
4) Patients who cannot see the monitor
5) There are serious complications that are not medically controlled

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Tatsuya
Middle name Tatsuya
Last name Kaneno

Organization

Tokyo Metropolitan University

Division name

Department of Occupational Therapy

Zip code

116-8551

Address

7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan 116-8551

TEL

03-3819-1211

Email

kaneno@tmu.ac.jp


Public contact

Name of contact person

1st name Kaneno
Middle name
Last name Tatsuya

Organization

Tokyo Metropolitan University

Division name

Department of Occupational Therapy

Zip code

116-8551

Address

7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan 116-8551

TEL

03-3819-1211

Homepage URL


Email

kaneno@tmu.ac.jp


Sponsor or person

Institute

Tokyo Metropolitan University

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI Grant Number JP 18K17762

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

JSPS KAKENHI Grant Number JP18K17762.


IRB Contact (For public release)

Organization

Tokyo Metropolitan University

Address

7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan 116-8551

Tel

03-3819-1211

Email

rinri-hs@tmu.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

2021 Year 09 Month 16 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

Open public recruiting

Date of protocol fixation

2019 Year 12 Month 20 Day

Date of IRB

2019 Year 12 Month 20 Day

Anticipated trial start date

2021 Year 09 Month 15 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 09 Month 12 Day

Last modified on

2023 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051905


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name