UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050738
Receipt number R000057812
Scientific Title Preparation of the guideline index about wheelchair seated posture during upper extremity activity focusing on lower extremity position
Date of disclosure of the study information 2023/03/31
Last modified on 2023/09/29 11:40:17

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Basic information

Public title

Preparation of the guideline index about wheelchair seated posture during upper extremity activity focusing on lower extremity position

Acronym

Preparation of the guideline index about wheelchair seated posture during upper extremity activity focusing on lower extremity position

Scientific Title

Preparation of the guideline index about wheelchair seated posture during upper extremity activity focusing on lower extremity position

Scientific Title:Acronym

Preparation of the guideline index about wheelchair seated posture during upper extremity activity focusing on lower extremity position

Region

Japan


Condition

Condition

Healthy adults and General or MCI elderly

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To suggest the guideline index about wheelchair seated posture which easy to perform upper extremity activities, investigating the effect of lower limb position on upper limb operability

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Score of Wheelchair Seating Arm Function Test
Seated pressure

Key secondary outcomes



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

Test on wheelchair seated posture using foot support or foot stool

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

People with consent for this study
CRD2 or less
Able to maintain sitting position for more than 30 minutes

Key exclusion criteria

People with unstable general condition
CDR3 or higher

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Abe

Organization

Tokachi Rehabilitation center

Division name

Department of Rehabilitation

Zip code

080-0833

Address

2-1 kisen, inadachou, obihiro, Hokkaido, Japan

TEL

0155-47-5700

Email

ot-abe@hokuto7.or.jp


Public contact

Name of contact person

1st name Atsuki
Middle name
Last name Ukita

Organization

Tohoku Fukushi University

Division name

Faculty of Health Science

Zip code

989-3201

Address

6-149-1, Kunimigaoka, Aoba-ku, sendai, Miyagi, Japan

TEL

022-728-6013

Homepage URL


Email

a-ukita@tfu.ac.jp


Sponsor or person

Institute

Tohoku Fukushi Univeisity, Faculty of Health Science, Atsuki Ukita.

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional review board of Hokuto Social Medical Corporation

Address

7-5 Kisen, inadacyou, Obihiro, Hokkaido, Japan

Tel

0155-48-8000

Email

crc@hokuto7.or.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

2023 Year 03 Month 31 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

2022 Year 08 Month 24 Day

Date of IRB

2022 Year 08 Month 24 Day

Anticipated trial start date

2022 Year 09 Month 01 Day

Last follow-up date

2023 Year 09 Month 30 Day

Date of closure to data entry

2023 Year 09 Month 30 Day

Date trial data considered complete

2023 Year 09 Month 30 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2023 Year 03 Month 31 Day

Last modified on

2023 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057812