UMIN-CTR Clinical Trial

Basic information
Public title	Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Acronym	Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Scientific Title	Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Scientific Title:Acronym	Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Region	Japan

Condition
Condition	First stroke patient with unilateral motor deficits
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of dynamic sitting exercise to anteroposterior and mediolateral direction with delayed visual feedback in early phase after stroke
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Postural Assessment Scale for Stroke
Key secondary outcomes	Dynamic sitting task Sit-to-stand task Change of center of pressure movement in the daily intervention Stroke Impairment Assessment Set Trunk Impairment Scale Functional Ambulation Category Functional Independence Measure - motor items

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Experimental group Dynamic sitting exercise to anteroposterior and mediolateral direction with delayed visual feedback (30 times for each direction per session, 5 sessions a week)
Interventions/Control_2	Control group Dynamic sitting exercise to anteroposterior and mediolateral direction with conventional visual feedback (30 times for each direction 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	-within 30 days from onset -over 20 years old -able to perform the task -able to sit without upper limb support -able to understand the instruction contents -no problem for visual or visuospatial perception -no previous history of neurological diseases other than stroke -no orthopedic disease influenced on measurement or intervention -signed informed consent
Key exclusion criteria	none
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Masahide Middle name Last name Inoue
Organization	Saitama medical university international medical center
Division name	Rehabilitation center
Zip code	350-1298
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 Masahide Middle name Last name Inoue
Organization	Saitama medical university international medical center
Division name	Rehabilitation center
Zip code	350-1298
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	Saitama medical university international medical center clinical research IRB
Address	1397-1, Yamane, Hidaka city, Saitama
Tel	042-984-4523
Email	chikens@saitama-med.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	2020 Year 06 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	27
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	Main results already published
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB	2020 Year 04 Month 08 Day
Anticipated trial start date	2020 Year 07 Month 10 Day
Last follow-up date	2021 Year 08 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	2020 Year 06 Month 25 Day
Last modified on	2022 Year 07 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046703