UMIN-CTR Clinical Trial

Basic information
Public title	Clinical application of robotic wear (Curara) for patients with neuromuscular disorders
Acronym	Clinical application of robotic wear (Curara) for patients with neuromuscular disorders
Scientific Title	Clinical application of robotic wear (Curara) for patients with neuromuscular disorders
Scientific Title:Acronym	Clinical application of robotic wear (Curara) for patients with neuromuscular disorders
Region	Japan

Condition
Condition	spinocerebellar degeneration, multiple system atrophy, spinal muscular atrophy (including spinal bulbar muscular atrophy), muscular dystrophy
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to assist the patients with neuromuscular disorders to walk
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) interactive torque (joint torque) 2) angular velocity (rad/s) & angular acceleration (rad/s2)
Key secondary outcomes

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	to assess the efficacy of robotic wear (Curara) on walking
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	adult patients with the conditions described above who are able to stand and walk independently
Key exclusion criteria	patients with the age under 20 years old, or patients who are not able to stand or walk independently, even if they have the conditions decribed above
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Kunihiro Middle name Last name Yoshida
Organization	Shinshu University
Division name	School of Medicine, Department of Brain Disease Research
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto 390-8621
TEL	0263-37-2673
Email	kyoshida@shinshu-u.ac.jp

Public contact
1st name of contact person	1st name Kunihiro Middle name Last name Yoshida
Organization	Shinshu University
Division name	School of Medicine, Department of Brain Disease Research
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto 390-8621
TEL	0263-37-2673
Homepage URL
Email	kyoshida@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Medicine, Department of Brain Disease Research
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Sceience and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	the Committee for Medical Ethics of Shinshu University School of Medicine
Address	3-1-1 Asahi, Matsumoto 390-8621
Tel	0263-37-2572
Email	mdrinri@shinshu-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	信州大学医学部附属病院（長野県）、信州大学医学部旭総合研究棟（長野県）、信州大学大学院生命機能・ファイバー工学専攻感性システム工学講座（長野県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	25
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	Completed
Date of protocol fixation	2014 Year 04 Month 09 Day
Date of IRB	2014 Year 04 Month 08 Day
Anticipated trial start date	2014 Year 04 Month 21 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study was completed by the end of March, 2019, and followed by the clinical research named as "Rehabilitation trial using robotec wear curara for patients with cerebrovascular and neurodegenerative diseases (part 1: cerebrovascular disease; part 2: spinocerebellar degeneration)". This trials are sponsored by Japan Agency for Medical Research and Development (AMED) and have started on October 3, 2018. Two different clinical trials are now on going (cerebrovascular disease: jRCTs032180163; spinocerebellar degeneration: jRCTs032180164).

Management information
Registered date	2014 Year 04 Month 15 Day
Last modified on	2019 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016020