UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between the changes in spinal reflexes and motor function, gait pattern in patients with chronic stroke
Acronym	The relationship between spinal reflexes and gait pattern after chronic stroke
Scientific Title	The relationship between the changes in spinal reflexes and motor function, gait pattern in patients with chronic stroke
Scientific Title:Acronym	The relationship between spinal reflexes and gait pattern after chronic stroke
Region	Japan

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

Objectives
Narrative objectives1	To examine the relationship between the changes in spianl reflexes (heteronymous facilitation, reciprocal inhibition) and motor funcion in affected leg, abnormal gait pattern in patients with chronic stroke.
Basic objectives2	Others
Basic objectives -Others	cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	heteronymous facilitation, reciprocal inhibition
Key secondary outcomes	Motor function (Fugl-Meyer assessment, Stroke Impairment Assessment Set), Spasticity (Modified Ashworth scale, E-SAM), gait (video analysis)

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	1.First cerebral infarction or hemorrhage with single lesion 2.over 180 days after the onset of stroke 3.Modified Ashworth scale (MAS) score is 2 or less 4.Functional Independence Measure (FIM) walking score is 3 or more 5.Able to come to hospital independently 6.Comminication possible 7.Agreement to participate in the study
Key exclusion criteria	1.Medical history of orthopedic disease of leg 2.Medical history of diabetic peripheral neuropathy 3.Implanted electronic pacing or defibrillation devices 4.Receiving antispastic medication during participation in the study 5.Sensory loss on affected leg 6.Stop by primary doctor
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Michiyuki Middle name Last name Kawakami
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	275-0026
Address	4-1-1 Yatsu, Narashino-shi, Chiba
TEL	047-453-9000
Email	michiyukikawakami@hotmail.com

Public contact
Name of contact person	1st name Yoko Middle name Last name Takahashi
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	275-0026
Address	4-1-1 Yatsu, Narashino-shi, Chiba
TEL	047-453-9000
Homepage URL
Email	matsuda_y@a6.keio.jp

Sponsor
Institute	Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Tokyo Bay Rehabilitation Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Tokyo Bay Rehabilitation Hospital
Address	4-1-1 Yatsu, Narashino-shi, Chiba
Tel	047-453-9000
Email	shinsakai@wanreha.net

Secondary IDs
Secondary IDs	YES
Study ID_1	194
Org. issuing International ID_1	Tokyo Bay Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京湾岸リハビリテーション病院

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 13 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	16
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	No longer recruiting
Date of protocol fixation	2018 Year 02 Month 13 Day
Date of IRB	2018 Year 02 Month 13 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2023 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We test the relationship among each evaluation factor at the same time. We compare the state of evaluations with that in patients with sub-acute stroke.

Management information
Registered date	2018 Year 10 Month 12 Day
Last modified on	2021 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039304