UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041050
Receipt No. R000046876
Scientific Title Verification of the effect for improve walking ability using cushion for stand up training
Date of disclosure of the study information 2020/07/09
Last modified on 2020/07/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 09 Day
Last modified on
2020 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046876

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.