UMIN-CTR Clinical Trial

Basic information
Public title	Study to evaluate effects of robot suit HAL in combination with acupuncture treatment
Acronym	Study to evaluate effects of robot suit HAL in combination with acupuncture treatment
Scientific Title	Study to evaluate effects of robot suit HAL in combination with acupuncture treatment
Scientific Title:Acronym	Study to evaluate effects of robot suit HAL in combination with acupuncture treatment
Region	Japan

Condition
Condition	Movement disorder
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to contribute to restoration of motor function by rehabilitation using HAL, in combination with acupuncture or moxibustion treatment to reduce spasm and flaccid of muscle that interfere with walking training.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Barthel Index
Key secondary outcomes	1.Brunnstrom stage 2.Fugl-Meyer Assessment 3.Modified Ashworth Scale 4.10m walking test 5.chair-stand test 6.Functional Independence Measure 7.VAS 8.Subjective walking evaluation 9.Myogenic Potential Measuring Apparatus 10.fNIRS

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	Other
Interventions/Control_1	Acupuncture treatment Exercise training using HAL
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	Patients with lower limb motor paralysis who have good conscious state and stable state of the whole body, and can judge safety, danger etc.
Key exclusion criteria	1. Significant lower limb joint disability (strong deformation, inflammation, dislocation, etc.) 2. Cardiac pacemaker wearer, Pregnant 3. Higher brain dysfunction, dementia, severe sensory disorder 4. Difficult to hold the sitting posture 5. Do not fit the size of HAL 6. Abdominal pressure difficulty 7. Judged by doctors not to be applied
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ko Nishimura
Organization	Suzuka University of Medical Science
Division name	Institute of Traditional Chinese Medicine
Zip code
Address	1275-3, Kishioka,Suzuka-city, Mie, JAPAN
TEL	059-381-2385
Email	ko-n@suzuka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ken Takagi
Organization	Suzuka University of Medical Science
Division name	Institute of Traditional Chinese Medicine
Zip code
Address	1275-3, Kishioka,Suzuka-city, Mie, JAPAN
TEL	059-381-2385
Homepage URL
Email	takagi17@suzuka-u.ac.jp

Sponsor
Institute	Suzuka University of Medical Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 07 Month 01 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	2017 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date	2017 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 30 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032078

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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