UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040191 |
|---|---|
| Receipt number | R000045763 |
| Scientific Title | Impact on lower extremity function of long-leg orthosis in stroke patients Focus on muscle tone |
| Date of disclosure of the study information | 2020/04/18 |
| Last modified on | 2022/11/01 17:28:04 |
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Basic information
Public title
Impact on lower extremity function of long-leg orthosis in stroke patients
Focus on muscle tone
Acronym
indication of KAFO
Scientific Title
Impact on lower extremity function of long-leg orthosis in stroke patients
Focus on muscle tone
Scientific Title:Acronym
indication of KAFO
Region
| Japan |
Condition
Condition
cerebral infarction
cerebral hemorrhage
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the validity of using KAFO early after the onset of stroke by examining lower limb muscle tone, pain and daily activities.
By clarifying the effects of the use of lower limb orthoses on the physical activity of stroke patients early after the onset of stroke, if the advantages and disadvantages of using lower limb orthoses become clear, determine the timing of preparation and duration of use It will be an indicator.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Modified Tardieu scale(MTS)
muscle tone examination
Key secondary outcomes
evaluation of pain
SIAS
Fugl-Meyer assessment
Functional Independence measure : FIM
1 time every 2 weeks
Until discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Standing training and gait training during physical therapy with long leg brace.
Interventions/Control_2
Standing training and walking training during physical therapy without wearing long leg brace.
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.First stroke patient (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) who was admitted to Onishi Neurosurgery Hospital and was prescribed physiotherapy
2.The wearing time is decided based on the wearing adaptation table
3.Consciousness disorder JCS single digit or less
4.Understand verbal instructions
5.Sitting is possible (may be assisted)
6.Non-paretic side lower limb muscle strength MMT4 or higher
Key exclusion criteria
If you have a history of diabetes mellitus or spinal cord / spinal cord disease
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | nobuhiko |
| Middle name | |
| Last name | iwai |
Organization
kobe gakuin university
Division name
Faculty of Rehabilitation
Zip code
652-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi
TEL
078-974-1551
iwai@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | takahiro |
| Middle name | |
| Last name | yoshino |
Organization
ohnishi neurological center
Division name
department of rehabilitation
Zip code
674-0064
Address
1661-1 eigashima,okubo-tyou,akashi city
TEL
078-938-1257
Homepage URL
y-takahiro310@msn.com
Sponsor or person
Institute
kobe gakuin university
Institute
Department
Personal name
Funding Source
Organization
kobe gakuin university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kobe gakuin university
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi
Tel
078-974-4297
iwai@j.kobegakuin.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
医療法人社団英明会、大西脳神経外科病院(兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 18 | 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
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 18 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045763
