UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055782 |
|---|---|
| Receipt number | R000063752 |
| Scientific Title | Verification of methods for reducing the Late Braking Force of stroke patients |
| Date of disclosure of the study information | 2024/10/08 |
| Last modified on | 2024/10/08 16:22:00 |
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Basic information
Public title
Verification of methods for reducing the Late Braking Force of stroke patients
Acronym
Verification of methods for reducing the Late Braking Force of stroke patients
Scientific Title
Verification of methods for reducing the Late Braking Force of stroke patients
Scientific Title:Acronym
Verification of methods for reducing the Late Braking Force of stroke patients
Region
| Japan |
Condition
Condition
hemiplegic stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will verify the effectiveness of a walking aid device that reduces late braking force in patients with chronic stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
We will measure the Late Braking Force that appears in the later stages of paralysis with and without the use of a walking aid device.
Key secondary outcomes
Walking speed
Stride length (paretic and non-paretic sides)
Propulsion force of the paretic lower limb
Tailing limb angle
Coordination between segments of the paretic and non-paretic lower limbs
Fugl Myer Assessment
Trunk Control Test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Comparison of walking ability with and without the use of a walking aid device (simultaneous use of an electronically controlled knee brace and a torso and hip joint support vest)
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient has hemiplegia due to a stroke
The patient can walk with the aid of a walking aid (crutch, ankle-foot orthosis) or with supervision
The patient understands the research content and gives consent
Key exclusion criteria
Persons with higher brain dysfunction, ataxia, orthopedic disorders, or joint contractures that affect walking
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Ohata |
Organization
Reiwa Health Sciences University
Division name
School of Physical Therapy Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12, wajirogaoka, Higashi-ku, Fukuoka, Japan
TEL
092-607-6701
m.ota@kyoju.ac.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Ohta |
Organization
Reiwa Health Sciences University
Division name
School of Physical Therapy Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12, wajirogaoka, Higashi-ku, Fukuoka, Japan
TEL
092-607-6701
Homepage URL
m.ota@kyoju.ac.jp
Sponsor or person
Institute
Reiwa Health Sciences University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reiwa Health Sciences University
Address
2-1-12, wajirogaoka, Higashi-ku, Fukuoka, Japan
Tel
092-607-6701
m.ota@kyoju.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
| 2024 | Year | 10 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063752
