UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043424
Receipt number R000049312
Scientific Title Verification of the effect on satisfaction of load training device with sound feedback
Date of disclosure of the study information 2021/02/24
Last modified on 2022/01/19 16:07:26

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Basic information

Public title

Verification of the effect on satisfaction of load training device with sound feedback

Acronym

Verification of the effect on satisfaction of load training device with sound feedback

Scientific Title

Verification of the effect on satisfaction of load training device with sound feedback

Scientific Title:Acronym

Verification of the effect on satisfaction of load training device with sound feedback

Region

Japan


Condition

Condition

legs fracture

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Use load training equipment for patients in the partial load phase after legs fracture to verify the superiority of the equipment in terms of satisfaction.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Satisfaction score(SUS Score)
Measured after 3 days of use

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

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

Use of load training equipment by a physiotherapist for 20 minutes a day for 3 days

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with legs fractures during partial load period.
Patients with reduced walking ability.
Patients in the recovery phase rehabilitation ward of Matsuyama Rehabilitation Hospital.
Patients who can give written consent.

Key exclusion criteria

Patients whose function may be reduced by using the developed equipment.
Patients with reduced cognitive function.(MMSE<=23)
Undernourished patients.(ALB <= 3.0 [g/dl])
Those who cannot wear commercially available shoes due to illness

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Yoshikawa

Organization

National Institute of Technology, Niihama College

Division name

Department of Mechanical Engineering

Zip code

792-8580

Address

Yagumotyo 7-1, Niihama City, Ehime Pref., Japan

TEL

0897-37-7701

Email

yosikawa@mec.niihama-nct.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Yoshikawa

Organization

National Institute of Technology, Niihama College

Division name

Department of Mechanical Engineering

Zip code

792-8580

Address

Yagumotyo 7-1, Niihama City, Ehime Pref., Japan

TEL

0897-37-7701

Homepage URL


Email

yosikawa@mec.niihama-nct.ac.jp


Sponsor or person

Institute

National Institute of Technology, Niihama College

Institute

Department

Personal name



Funding Source

Organization

TOSA ELECTRONICS IND.CO.,LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Matsuyama Rehabilitation Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Bioethics Committee of shikokutiku KOSEN

Address

Tyokushityo 355,Takamatsu City, Kagawa Pref.

Tel

087-869-3818

Email

kenkyu@t.kagawa-nct.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 02 Month 24 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

9

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

2020 Year 02 Month 14 Day

Date of IRB

2020 Year 06 Month 08 Day

Anticipated trial start date

2021 Year 03 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 01 Month 02 Day

Date trial data considered complete

2022 Year 01 Month 02 Day

Date analysis concluded

2022 Year 01 Month 11 Day


Other

Other related information



Management information

Registered date

2021 Year 02 Month 24 Day

Last modified on

2022 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049312


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name