UMIN-CTR Clinical Trial

Basic information
Public title	Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait
Acronym	Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait
Scientific Title	Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait
Scientific Title:Acronym	Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait
Region	Japan

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

Objectives
Narrative objectives1	Walking rehabilitation using a supporting device for hip joint movement effects on patients with hemiplegic gait
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gait Assessment and Intervention Tool
Key secondary outcomes	electromyography Brunstrom stage modified Ashworth scale Functional Ambulation Categories 10m walking test sensory test knee extension muscle strength test one leg standing

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Perform rehabilitation for 2 weeks using a walking assist robot
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Walkable convalescent stroke patients
Key exclusion criteria	consciousness disturbance advanced dementia or communicative difficulties Cause other neuromuscular complications Undergo surgical treatments
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Egashira
Organization	Suita Municipal Hospital
Division name	Department of Rehabilitation medicine
Zip code	564-8567
Address	5-7 kishibeshinmachi suita Osaka japan
TEL	06-6387-3311
Email	reha@mhp.suita.osaka.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Matsumoto
Organization	Suita Municipal Hospital
Division name	Department of Rehabilitation medicine
Zip code	564-8567
Address	5-7 kishibeshinmachi suita Osaka japan
TEL	06-6387-3311
Homepage URL
Email	reha@mhp.suita.osaka.jp

Sponsor
Institute	Suita Municipal Hospital
Institute
Department

Funding Source
Organization	Suita Municipal Hospital
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	Suita Municipal Hospital
Address	5-7 kishibeshinmachi suita Osaka japan
Tel	06-6387-3311
Email	kodama7899@mhp.suita.osaka.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	2020 Year 08 Month 20 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	Terminated
Date of protocol fixation	2020 Year 08 Month 06 Day
Date of IRB	2020 Year 11 Month 11 Day
Anticipated trial start date	2020 Year 11 Month 11 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 19 Day
Last modified on	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047317