UMIN-CTR Clinical Trial

Basic information
Public title	The effect of neuro-rehabilitation on walking ability after stroke
Acronym	The effect of neuro-rehabilitation on walking ability after stroke
Scientific Title	The effect of neuro-rehabilitation on walking ability after stroke
Scientific Title:Acronym	The effect of neuro-rehabilitation on walking ability after stroke
Region	Japan

Condition
Condition	Cerebrovascular diseases
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of this study are to examine the effect of action observation treatment on motor function and walking ability
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Brunnstrom stage Wisconsin gait scale
Key secondary outcomes	Functional magnetic resonance imaging

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Action observation treatment
Interventions/Control_2	Normal rehabilitation
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	18 years-old <=
Age-upper limit	76 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Ischemic or hemorrhagic stroke patients 2) 7 to 14 days from onset 3) Motor weakness of the lower extremities(Brunnstrom stage is more than II) 4) Sitting position possible 5) age of the patient is more than 18 and less than 76 at the date of registration 6) informed consent was obtained from the patient
Key exclusion criteria	1) patients with a history of cerebrovascular diseases 2) patients with orthopedic disease of the lower extremities 3) patients with severe neglect 4) patients with visual dysfunction 5) patients with severe cognitive dysfunction
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Nagahiro
Organization	University of Tokushima
Division name	Neurosurgery
Zip code	770-8503
Address	3-18-15, Kuramoto-cho, Tokushima
TEL	088-633-7149
Email	neuros@clin.med.tokushima-u.ac.jp

Public contact
Name of contact person	1st name Yoshiteru Middle name Last name Tada
Organization	University of Tokushima
Division name	Neurosurgery
Zip code	770-8503
Address	3-18-15, Kuramoto-cho, Tokushima
TEL	088-633-7149
Homepage URL
Email	neuros@clin.med.tokushima-u.ac.jp

Sponsor
Institute	University of Tokushima
Institute
Department

Funding Source
Organization	University of Tokushima, Department of Neurosurgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	University of Tokushima, Department of Neurosurgery
Address	3-18-15, Kuramoto-cho, Tokushima
Tel	088-633-7149
Email	neuros@clin.med.tokushima-u.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	2014 Year 12 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/32234334/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/32234334/
Number of participants that the trial has enrolled	16
Results	A split plot design analysis of covariance revealed no significant interactions between the assessment time and group in FAC and 10-meter walk test. However, the action observation treatment group (but not the control group) exhibited significant improvements in the 10-meter walk test the participants who could walk independently.
Results date posted	2022 Year 05 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Participants were patients who had been admitted to the stroke care unit of Tokushima University Hospital from December 2014 to April 2018. Exclusion criteria were stroke patients with a prior history of stroke, unilateral spatial neglect, visual impairment that interfered with the study protocol, major cognitive problems, and orthopedic disease of the lower limbs.
Participant flow	Participants were patients who had been admitted to the stroke care unit of Tokushima University Hospital from December 2014 to April 2018. We explained the purpose and procedure of the study to participants and received written informed consent from all participants.
Adverse events	None.
Outcome measures	Functional Ambulation Classification 10-meter walk test Brunnstrom stage
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 19 Day
Date of IRB	2014 Year 11 Month 28 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2020 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	2014 Year 11 Month 19 Day
Last modified on	2022 Year 05 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018267