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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name