UMIN-CTR Clinical Trial

Basic information
Public title	Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement
Acronym	Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement
Scientific Title	Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement
Scientific Title:Acronym	Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement
Region	Japan

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

Objectives
Narrative objectives1	To investigate the immediate effect of quick trunk movement on lower limb function and walking ability in stroke patients and its mechanism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gait speed
Key secondary outcomes	Coefficient of variation of gait Gait symmetry Muscle strength of knee extension Rate of force development of knee extension

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	quick trunk movement/Number of interventions: 1/pre-intervention/post-intervention
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subacute stroke patients with hemiplegia 2. A person who is able to walk with light assistance or independence with a cane or self-walk
Key exclusion criteria	1. People with severe dementia or higher brain dysfunction who have difficulty understanding the task 2. Individuals with medical and surgical disease that affect the measurement of gait and lower extremity motor function to a degree that affects the measurement of gait and lower extremity motor function 3.Those who exceed the Anderson - Doi criteria by measuring lower extremity motor function 4. Those who received botulinum toxin therapy for the lower extremities within 6 months
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tsubasa Middle name Last name ito
Organization	Sakurakai Hospital
Division name	rehabilitation department
Zip code	589-0011
Address	5-2610-1 Handa, Osakasayamashi, Osaka prefecture, Japan
TEL	072-366-5757
Email	itoresearch283@gmail.com

Public contact
Name of contact person	1st name Tsubasa Middle name Last name Ito
Organization	Sakurakai Hospital
Division name	rehabilitation department
Zip code	589-0011
Address	5-2610-1 Handa, Osakasayamashi, Osaka prefecture, Japan
TEL	072-366-5757
Homepage URL
Email	itoresearch283@gmail.com

Sponsor
Institute	Sakurakai Hospital
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	Sakurakai Hospital
Address	5-2610-1 Handa, Osakasayamashi, Osaka prefecture, Japan
Tel	072-366-5757
Email	itoresearch283@gmail.com

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	2021 Year 10 Month 04 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	10
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	2021 Year 07 Month 01 Day
Date of IRB	2021 Year 09 Month 24 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2023 Year 03 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	2021 Year 10 Month 04 Day
Last modified on	2022 Year 09 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052116