UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the effect for improve recovery using cushion for stand up training
Acronym	Verification of the effect for improve recovery using cushion for stand up training
Scientific Title	Verification of the effect for improve walking ability using cushion for stand up training
Scientific Title:Acronym	Verification of the effect for improve walking ability using cushion for stand up training
Region	Japan

Condition
Condition	Reduced walking ability
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will use the newly developed training cushion for elderly people with reduced walking ability in training to verify the superiority of the device in improving walking durability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Training efficiency obtained by dividing the difference in walking distance for 6 minutes measured before and after the test period by each training time
Key secondary outcomes	6 minute walking distance difference measured before and after the test period. Training time.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Except for the rehabilitation time conducted by the physiotherapist, two sets of stand up training are performed 10 times a day using a rising training cushion with a valid test period of at least 5 days a week for 4 weeks.
Interventions/Control_2	Except for the rehabilitation time conducted by the physiotherapist,exercise training at a distance set by a physiotherapist, with a valid test period of 5 weeks or more,
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 reduced walking ability. Patients with reduced lower limb muscle strength. Patients who can give written consent. Patients in the recovery phase rehabilitation ward of Matsuyama Rehabilitation Hospital.
Key exclusion criteria	Patients whose function may be reduced by using the developed equipment. Patients who have limited range of motion due to the effects of orthopedic diseases and have difficulty using developed equipment. Patients with reduced cognitive function.(MMSE<=23) Undernourished patients.(ALB <= 3.0 [g/dl]) Patients with reduced renal function.(eGFR < 60 [mL/min/1.73m2]) Patients with reduced cardiac function.(NYHA 3 to 4 or LFVE <= 50[%]) Patients with reduced respiratory function.(H-J class 3 to 4) Patients with high orderer brain dysfunction.
Target sample size	28

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	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Matsuyama Rehabilitation Hospital
Name of secondary funder(s)	Sanko Co., Ltd.

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	2020 Year 07 Month 09 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	18
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	2019 Year 04 Month 10 Day
Date of IRB	2019 Year 06 Month 03 Day
Anticipated trial start date	2020 Year 07 Month 10 Day
Last follow-up date	2021 Year 07 Month 10 Day
Date of closure to data entry	2021 Year 12 Month 20 Day
Date trial data considered complete	2021 Year 12 Month 20 Day
Date analysis concluded	2021 Year 12 Month 27 Day

Other
Other related information

Management information
Registered date	2020 Year 07 Month 09 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=R000046876