UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058042 |
|---|---|
| Receipt number | R000066344 |
| Scientific Title | Investigation of the Immediate Effects of Crouch Gait Training on Walking in Patients with Post-Stroke Hemiparesis |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/02 02:10:52 |
* 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
Investigation of the Immediate Effects of Crouch Gait Training on Walking Performance in Patients with Post-Stroke Hemiparesis
Acronym
Immediate Effects of Crouch Gait Training in Patients with Post-Stroke Hemiparesis
Scientific Title
Investigation of the Immediate Effects of Crouch Gait Training on Walking in Patients with Post-Stroke Hemiparesis
Scientific Title:Acronym
Immediate Effects of Crouch Gait Training in Patients with Stroke Hemiparesis
Region
| Japan |
Condition
Condition
Post-Stroke Hemiparetic Patients
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in lower limb joint angles and walking speed during normal gait before and after the implementation of crouch gait training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gait function (walking speed, cadence, step length)
Joint angles of the paretic hip and knee
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To perform 10 minutes of walking while maintaining flexion of the hip and knee joints
Interventions/Control_2
To perform normal walking for 10 minutes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with stroke
Able to walk without assistance from others
Able to walk without using a wheeled walking aid
No limitation in range of motion of the paretic hip or knee joints
No cerebellar lesions or resting tremors
Key exclusion criteria
No exclusion criteria
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwata |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka, Japan.
TEL
072-950-2111
iwata@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yosahihiko |
| Middle name | |
| Last name | Kawamoto |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka, Japan.
TEL
072-950-2111
Homepage URL
sf22262u@st.omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan 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 of the Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
3-7-30 Habikino, Habikino city, Osaka, Japan.
Tel
072-950-2111
iwata@omu.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
| 2025 | Year | 06 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066344
