UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055041 |
|---|---|
| Receipt number | R000062882 |
| Scientific Title | Developing guidelines for selectin Ankle-Foot orthosis joints function for stroke survivors. |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/07/22 15:11:24 |
* 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
Research to develope guidelines for selecting ankle joint function in Ankle-Foot orthotics for stroke survivors.
Acronym
Research to develope guidelines for selecting ankle joint function in Ankle-Foot orthosis for stroke survivors.
Scientific Title
Developing guidelines for selectin Ankle-Foot orthosis joints function for stroke survivors.
Scientific Title:Acronym
Developing guidelines for selectin Ankle-Foot orthosis joints function for stroke survivors.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the appropriate ankle joint function for each gait pattern of stroke victims by knee joint movement using a functionally adjustable Ankle Foot orthosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee joint angle during gait
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Useing the Ankle Foot Orthosis
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were as follows: first stroke survivors who were able to walk 10 m under observation, and who exhibited a gait pattern of excessive knee joint extension and excessive knee joint flexion during the stance phase.
Key exclusion criteria
Exclusion criteria are: patients with a history of orthopedic diseases that affect walking (e.g., lower limb fractures, rheumatism), severe dementia, and severe psychiatric disorders.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Soji |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University of Health and Welfare
Division name
Depertment of Prosthetics, Orthotics and Assitive Technology Facluty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city Niigata
TEL
+81-25-257-4579
soji-tanaka@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Soji |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University of Health and Welfare
Division name
Depertment of Prosthetics, Orthotics and Assitive Technology Facluty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city Niigata
TEL
+81-25-257-4579
Homepage URL
soji-tanaka@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-city Niigata
Tel
+81-25-257-4455
rinri@nuhw.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 | 08 | Month | 01 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | 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
| 2024 | Year | 07 | Month | 22 | Day |
Last modified on
| 2024 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062882
