UMIN-CTR Clinical Trial

Basic information
Public title	Effect of lateral wedge for standing balance capacity in patients with acute stroke -a randomized controlled trial -
Acronym	Effect of lateral wedge for standing balance capacity in patients with acute stroke -a randomized controlled trial -
Scientific Title	Effect of lateral wedge for standing balance capacity in patients with acute stroke -a randomized controlled trial -
Scientific Title:Acronym	Effect of lateral wedge for standing balance capacity in patients with acute stroke -a randomized controlled trial -
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of lateral wedge for standing balance capacity in patients with acute stroke
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Berg Balance Scale
Key secondary outcomes	Standing balance Stroke Impairment Assessment Set Trunk Control Test Trunk Impairment Scale Functional Ambulation Category Functional Independence Measure Kinematic analysis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Experimental group Reach exercise to non-paretic side on the lateral wedge (30 times per session, 5 sessions a week)
Interventions/Control_2	Control group Reach exercise to non-paretic side on the horizontal plane (30 times per session, 5 sessions a week)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)no history of stroke 2)within 30 days from onset 3)supratentorial lesion 4)over 20 years old 5)right handed 6)stable of neurological conditions 7)no respiratory and cardiovascular diseases 8)having a hemiparesis 9)signed informed consent
Key exclusion criteria	1)cannot understand the instruction 2)having mental disease or dementia 3)cannot execute the task due to musculoskeletal disease 4)Bilateral lesions
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahide Inoue
Organization	Saitama medical university international medical center
Division name	Rehabilitation center
Zip code
Address	1397-1, Yamane, Hidaka city, Saitama
TEL	042-984-4367
Email	mm0678@saitama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masahide Inoue
Organization	Saitama medical university international medical center
Division name	Rehabilitation center
Zip code
Address	1397-1, Yamane, Hidaka city, Saitama
TEL	042-984-4367
Homepage URL
Email	mm0678@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university international medical center
Institute
Department

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
Address
Tel
Email

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	2018 Year 04 Month 03 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	52
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	2018 Year 04 Month 03 Day
Date of IRB	2017 Year 12 Month 13 Day
Anticipated trial start date	2018 Year 04 Month 04 Day
Last follow-up date	2020 Year 02 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 03 Day
Last modified on	2021 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036608