UMIN-CTR Clinical Trial

Basic information
Public title	A feasibility traial of hand exoskeleton robot "Smove" which was designed to support impaired hand grip for post stroke patients in the daily living.
Acronym	A feasibility traial of "Smove"
Scientific Title	A feasibility traial of hand exoskeleton robot "Smove" which was designed to support impaired hand grip for post stroke patients in the daily living.
Scientific Title:Acronym	A feasibility traial of "Smove"
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the safty and efficacy of the hand exoskeleton robot "Smove" which was designed to support the daily living of post CVD patients who have impaired uppuer limb movement.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The normaloperation of "Smove" on patients. The sefety of "Smove" on patients. The improvement in the hand grip or pinch strength of the patients.
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	Wear the hand exoskeleton device "Smove" for maximum 1 hour.
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	Stroke survivor (over 5 days after onset) who has paresis in his or her upper limb. Who is over 20 years old age. Who can communicate properly. Whose recovery stage is Brunnstrom stage=> III in the arm Brunnstrom stage=> II in the hand Who can smoothly wear the "Smove" by himself or by caregiver. Who can make informed concent properly. (If the patient can't sign on the agreement document, a witness confirm the patient's agreement orally and sign on the agreement document on behalf of the patient)
Key exclusion criteria	The patient whose condition is not suitable for recieving rehabilitation thearapy. e.g. JCS =>10, SBP>180, DBP<80, HR >120/min Body temperature=> 38.0 degree Celsius. The patient who has strong pain in his impaired limb who has strong spascity (Ashworth =>3) who is recieving some therapy for spascity. The patient who has other serious condition or allergy.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Hashizume
Organization	Faculty of medical sciences, Kyushu University
Division name	Department of Advanced Medical Initiatives
Zip code
Address	3-1-1 Maidashi, Higasi-ku, Fukuoka City, Fukuoka, Japan
TEL	092-642-5592
Email	mhashi@dem.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Nobutaka Mukae
Organization	Faculty of medical sciences, Kyushu University
Division name	Neurosurgery
Zip code
Address	3-1-1 Maidashi, Higasi-ku, Fukuoka City, Fukuoka, Japan
TEL	092-642-5524
Homepage URL
Email	mukae@ns.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
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	2015 Year 05 Month 09 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	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Date of IRB	2014 Year 06 Month 30 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 05 Month 09 Day
Last modified on	2021 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020253