UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055561 |
|---|---|
| Receipt number | R000063446 |
| Scientific Title | Effectiveness of early intensive ankle joint training for stroke hemiplegia patients admitted to a recovery rehabilitation ward |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2025/10/21 13:57:10 |
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Basic information
Public title
Effectiveness of early intensive ankle joint training for stroke hemiplegia patients admitted to a recovery rehabilitation ward
Acronym
Effectiveness of Early Intensive Ankle Joint Training for Recovering Stroke Hemiplegic Patients
Scientific Title
Effectiveness of early intensive ankle joint training for stroke hemiplegia patients admitted to a recovery rehabilitation ward
Scientific Title:Acronym
Effectiveness of Early Intensive Ankle Joint Training for Recovering Stroke Hemiplegic Patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of early intensive ankle joint training on stroke hemiplegia patients admitted to a recovery rehabilitation ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle joint dorsiflexion active range of motion
Key secondary outcomes
Ankle joint dorsiflexion passive range of motion
Ankle dorsiflexor strength
modified ashworth scale
functional ambulation category
stroke impairment assessment set
Orthosis
walking aid
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 | Maneuver |
Interventions/Control_1
Joint range of motion training
Therapeutic Electrostimulation Therapy
Functional Electrostimulation Therapy
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
First stroke
Within 2 months of onset
Responsible lesion is on the tent
Independent walking before the disease
Patient has drooping legs and stumbles when walking or needs orthotics and up to light assistance
Able to dorsiflex the ankle joint on the paralyzed side, even partially
No history of metal implants such as pacemakers
Key exclusion criteria
Difficulty in understanding or training due to severe higher brain dysfunction or cognitive decline
History of significant osteoarticular or neo-major vascular disease
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Yamashige |
Organization
Midori hospital, general rehabilitation center
Division name
rehabilitation department
Zip code
9500983
Address
niigataken niigatashi chuuouku kandouji 2-5-1
TEL
0252440080
midori-pt@midori-gr.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Yamashige |
Organization
Midori hospital, general rehabilitation center
Division name
rehabilitation department
Zip code
9500983
Address
niigataken niigatashi chuuouku kandouji 2-5-1
TEL
0252440080
Homepage URL
midori-pt@midori-gr.jp
Sponsor or person
Institute
Midori hospital, general rehabilitation center
Institute
Department
Personal name
Funding Source
Organization
none
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
Midori hospital, general rehabilitation center
Address
niigataken niigatashi chuuouku kandouji 2-5-1
Tel
0252440080
midori-pt@midori-gr.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 | 09 | 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
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
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 21 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 21 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063446
