UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051109 |
|---|---|
| Receipt number | R000058093 |
| Scientific Title | Subjective need for ankle foot orthosis in stroke patients living at home and its relationship with changes in gait parameters with and without ankle foot orthosis |
| Date of disclosure of the study information | 2023/05/30 |
| Last modified on | 2024/05/20 16:46:35 |
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Basic information
Public title
Subjective need for ankle foot orthosis in stroke patients living at home and its relationship with changes in gait parameters with and without ankle foot orthosis.
Acronym
Subjective need for ankle foot orthosis in stroke patients living at home and its relationship with changes in gait parameters with and without ankle foot orthosis
Scientific Title
Subjective need for ankle foot orthosis in stroke patients living at home and its relationship with changes in gait parameters with and without ankle foot orthosis
Scientific Title:Acronym
Subjective need for ankle foot orthosis in stroke patients living at home and its relationship with changes in gait parameters with and without ankle foot orthosis
Region
| Japan |
Condition
Condition
stroke(cerebral infarction,cerebral hemorrhage,subarachnoid hemorrhage)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether the subjective need for ankle foot orthosis is related to the amount of change in gait parameters with and without ankle foot orthosis in stroke patients prescribed ankle foot orthosis and living at home.
Basic objectives2
Others
Basic objectives -Others
To determine the correlation between the subjective need for a ankle foot orthosis and the amount of change in gait parameters obtained in two conditions: with and without a short leg orthosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient's subjective need for ankle foot orthosis
Key secondary outcomes
walking speed
walking rate
stride length
body sway
fear
Timed up and go test
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 20-90 years who have been diagnosed with stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) and are living at home.
2.Patients are prescribed a ankle foot orthosis.
3.Subjects who are walking with ankle foot orthosis at the time of discharge from the hospital.
4.The patient is able to safely walk more than 14m without ankle foot orthosis by verbal instruction or observation without physical contact by a caregiver (Functional Ambulation Category 3 or above).
5.Written consent to participate in the study has been obtained from the subject or the subject's family.
Key exclusion criteria
1. Those with a score of III or IV in the Independence in daily living scale for the elderly with dementia.
2. Those who have difficulty in following the instructions due to obvious cognitive decline or severe aphasia.
3. Other subjects who are judged to be unsuitable by the principal investigator or the physician.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Shijima |
Organization
Saku Central Hospital
Division name
Department of Rehabilitation
Zip code
384-0301
Address
Usuda197,Saku,Nagano,Japan
TEL
0267-82-3131
pasutamaiteru.yo@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Shijima |
Organization
Saku Central Hospital
Division name
Department of Rehabilitation
Zip code
384-0301
Address
Usuda197,Saku,Nagano,Japan
TEL
0267-82-3131
Homepage URL
pasutamaiteru.yo@gmail.com
Sponsor or person
Institute
Saku Central Hospital
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
Saku Central Hospital Group Research Ethics Committee
Address
Usuda197,Saku,Nagano,Japan
Tel
0267-82-3131
irboffice@sakuhp.or.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
| 2023 | Year | 05 | Month | 30 | 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
| 2023 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 31 | Day |
Other
Other related information
In this study, we experimentally examine whether the amount of change in gait parameters with and without ankle foot orthosis is related to subjective need for ankle foot orthosis in stroke patients who are prescribed ankle foot orthosis and live at home.
Management information
Registered date
| 2023 | Year | 05 | Month | 19 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058093
