UMIN-CTR Clinical Trial

Basic information
Public title	Influence of toe grip strength on walking ability in home rehabilitation patients
Acronym	Influence of toe grip strength on gait in home rehabilitation
Scientific Title	Influence of toe grip strength on walking ability in home rehabilitation patients
Scientific Title:Acronym	Influence of toe grip strength on gait in home rehabilitation
Region	Japan

Condition
Condition	Cerebrovascular diseases, orthopedic diseases, internal disorders
Classification by specialty	Medicine in general Orthopedics Neurosurgery Cardiovascular surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate how toe grip strength affects gait function in order to obtain further useful evidence for home-based rehabilitation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Two-step test, one-legged standing time
Key secondary outcomes	Toe grip strength

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The regular home visit rehabilitation program in the control group focuses on whole-body coordination, joint range-of-motion exercises, muscle strengthening exercises, and basic movement practice, and is conducted on average twice a week according to the subject's needs and condition.
Interventions/Control_2	In addition to the regular visiting rehabilitation program, towel gathering practice is continued twice a week for about three months.
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	40 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Among those who use rehabilitation services by physical therapists or occupational therapists at visiting nursing stations, those who can walk at a level of watchful waiting or higher.
Key exclusion criteria	Subjects with malignant tumors or degenerative diseases, subjects whose conditions changed significantly due to hospitalization or other reasons during the evaluation period, and subjects who are unable to perform towel gathering exercises.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazunori Middle name Last name Kojima
Organization	Okayama Healthcare Professional University
Division name	Faculty of Health Sciences Department of Physical Therapy
Zip code	700-0913
Address	3-2-18,Daiku,Kitaku,Okayama,Okayama
TEL	086-233-8020
Email	kojima@opu.ac.jp

Public contact
Name of contact person	1st name Kazunori Middle name Last name Kojima
Organization	Okayama Healthcare Professional University
Division name	Faculty of Health Sciences Department of Physical Therapy
Zip code	700-0913
Address	3-2-18,Daiku,Kitaku,Okayama,Okayama
TEL	086-233-8020
Homepage URL
Email	kojima@opu.ac.jp

Sponsor
Institute	Okayama Healthcare Professional University
Institute
Department

Funding Source
Organization	Okayama Healthcare Professional University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama Healthcare Professional University
Address	3-2-18,Daiku,Kitaku,Okayama,Okayama
Tel	086-233-8020
Email	kojima@opu.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 04 Month 20 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	34
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	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 11 Month 17 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 20 Day
Last modified on	2021 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050090