UMIN-CTR Clinical Trial

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
Email	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
Email	y-takahiro310@msn.com

Sponsor
Institute	kobe gakuin university
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045763