UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of botulinum therapy to the lower limb for post-stroke spasticity using shear wave velocity.
Acronym	Evaluation of botulinum therapy for post-stroke spasticity using shear wave velocity.
Scientific Title	Evaluation of botulinum therapy to the lower limb for post-stroke spasticity using shear wave velocity.
Scientific Title:Acronym	Evaluation of botulinum therapy for post-stroke spasticity using shear wave velocity.
Region	Japan

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

Objectives
Narrative objectives1	The current study examined the effects of botulinum therapy through quantitative evaluation of spastic muscle stiffness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	spastic muscle stiffness
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	post-stroke paralysis of the lower limbs
Key exclusion criteria	(1) Age less than 20 years old, (2) bilateral cerebral hemispheric lesions, (3) Bilateral motor paralysis is still present, (4) Patients with a history of cervical spondylotic radiculopathy or peripheral neuropathy of the upper limbs, (5) Patients with a history of upper limb trauma or surgery.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Hasegawa
Organization	The Jikei University School of Medicine
Division name	Department of Rehabilitaion Medicine
Zip code	105-8461
Address	3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo
TEL	03-3433-1111
Email	hasegawa.yuki.reha@gmail.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Hasegawa
Organization	The Jikei University School of Medicine
Division name	Department of Rehabilitaion Medicine
Zip code	105-8461
Address	3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo
TEL	03-3433-1111
Homepage URL
Email	hasegawa.yuki.reha@gmail.com

Sponsor
Institute	The Jikei University School of Medicine Department of Rehabilitaion Medicine
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Jikei University School of Medicine
Address	3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo
Tel	03-3433-1111
Email	hasegawa.yuki.reha@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	2022 Year 10 Month 11 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 06 Month 30 Day
Date of IRB	2022 Year 09 Month 04 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	case series study

Management information
Registered date	2022 Year 10 Month 11 Day
Last modified on	2022 Year 10 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055868