UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042251 |
|---|---|
| Receipt number | R000048243 |
| Scientific Title | Muscle strength, rate of force development and walking ability in patients with stroke |
| Date of disclosure of the study information | 2020/10/28 |
| Last modified on | 2023/03/04 22:55:48 |
* 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
Muscle strength, rate of force development and walking ability in patients with stroke
Acronym
Muscle strength, rate of force development and walking ability in patients with stroke
Scientific Title
Muscle strength, rate of force development and walking ability in patients with stroke
Scientific Title:Acronym
Muscle strength, rate of force development and walking ability in patients with stroke
Region
| Japan |
Condition
Condition
1. Stroke
2. Elderly people
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between muscle strength, rate of force development and walking ability in patients with stroke
Basic objectives2
Others
Basic objectives -Others
A cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait speed, Coefficient of variation of stride time, Gait symmetry
Key secondary outcomes
Muscle strength of knee extension
Rate of force development of knee extension
Muscle strength of leg press
Rate of force development of leg press
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients
1. Subacute stroke patients with hemiplegia
2. A person who is able to walk with light assistance or independence with a cane or self-walk
Elderly people
1. Healthy elderly people living in the community
Key exclusion criteria
1. People with severe dementia or higher brain dysfunction who have difficulty understanding the task
2. Individuals with medical and surgical disease that affect the measurement of gait and lower extremity motor function to a degree that affects the measurement of gait and lower extremity motor function
3.Those who exceed the Anderson - Doi criteria by measuring lower extremity motor function
4. Those who received botulinum toxin therapy for the lower extremities within 6 months
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwata |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
TEL
072-950-2111
iwata@omu.ac.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Ito |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
TEL
072-950-2111
Homepage URL
itoresearch283@gmail.com
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee on Research Ethics, The Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
Tel
072-950-2111
yamamoto@rehab.osakafu-u.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 | 10 | Month | 28 | 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
27
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 | 10 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cross-sectional study
Stroke patients
Patients who were admitted to the Recovery Rehabilitation Unit of the Sakurakai Hospital between October 28, 2020 and March 31, 2023 and meet the selection criteria.
Elderly people
Healthy elderly people living in the community who meet the selection criteria.
Management information
Registered date
| 2020 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048243
