UMIN-CTR Clinical Trial

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
Institute	National Institute of Technology, Niihama College
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049312