UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043984 |
|---|---|
| Receipt number | R000050090 |
| Scientific Title | Influence of toe grip strength on walking ability in home rehabilitation patients |
| Date of disclosure of the study information | 2021/04/20 |
| Last modified on | 2021/10/20 10:38:22 |
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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
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
kojima@opu.ac.jp
Sponsor or person
Institute
Okayama Healthcare Professional University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050090
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
