UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of gait training with walking supportive robot on hemiplegic stroke patients: a crossover study of gait improvement
Acronym	Effectiveness of gait training with walking supportive robot
Scientific Title	Effectiveness of gait training with walking supportive robot on hemiplegic stroke patients: a crossover study of gait improvement
Scientific Title:Acronym	Effectiveness of gait training with walking supportive robot
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to verify the effects of robotic-assisted gait training to knee joint motion during walking on hemiplegic patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of 10m walking test with maximum speed before and after of walking practice
Key secondary outcomes	6-min walking distance Gait analysis index (3D motion analysis, surface electromyography analysis) Knee joint extensor muscle strength Balance ability (Berg Balance Scale, Mini-Balance Evaluation-Systems Test) Knee joint kinematic data using robotic-assisted walking

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	gait training with orthobot: assistive robot for walking learning (8 sessions, 20 minutes/session)
Interventions/Control_2	conventional gait training (8 sessions, 20 minutes/session)
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	First stroke and at least 6 months since single unilateral stroke onset Gait ability is 4 or more in Functional Ambulation Category
Key exclusion criteria	Severe cognitive disorders or higher brain dysfunction Respiratory, cardiac, urologic and digestive dysfunction that impedes training Neuromuscular or joint diseases affecting gait At resting heart beat 140 times / min or more, diastolic blood pressure of 120 mmHg or more, or systolic blood pressure of 200 mmHg or more Patients who received brain stimulation therapy (rTMS, TDCS), robotic-assisted training, or Botulinum toxin therapy within 3 months
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yuta Middle name Last name Chujo
Organization	Kansai Medical University Hospital
Division name	Department of Rehabilitation
Zip code	573-1191
Address	2-3-1, Shinmachi, Hirakata city, Osaka
TEL	+81-72-804-0101
Email	chujoyut@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Yuta Middle name Last name Chujo
Organization	Kansai Medical University Hospital
Division name	Department of Rehabilitation
Zip code	573-1191
Address	2-3-1, Shinmachi, Hirakata city, Osaka
TEL	+81-72-804-0101
Homepage URL
Email	chujoyut@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	None
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	Kansai Medical University Center for Ethical Review
Address	2-5-1 Shinmachi, Hirakata city, Osaka
Tel	+81-72-804-0101
Email	rinriirb@hirakata.kmu.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	2022 Year 11 Month 22 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
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	Enrolling by invitation
Date of protocol fixation	2022 Year 10 Month 27 Day
Date of IRB	2022 Year 11 Month 02 Day
Anticipated trial start date	2022 Year 11 Month 02 Day
Last follow-up date	2025 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	2022 Year 11 Month 22 Day
Last modified on	2022 Year 11 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056458