UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of functional recovery treatments on upper/lower extremity of stroke and fracture patients using art devices
Title of the study (Brief title)	Rehabilitation training with art devices for upper/lower extremity
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of art device training on upper/lower functions in stroke and fracture patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Profile of Mood States-Brief From Japanese Version Questionnaire of motivation TDMS-ST (Two-dimensional Mood Scale-Short Term) Number of exercises (number of exercises in 10 minutes)
Key secondary outcomes	Active range of motion (shoulder and elbow joint) Manual Muscle Test Simple Test for Evaluating Hand Function Hand Held Dynamometer (knee extension) 30-sec Chair Stand test (CS-30) Gait speed Functional Independence Measure Heart rate Fugl-Meyer Assessment Stroke Impairment Assessment Set Motor Activity Log Modified Ashworth Scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Devices for upper limb
Interventions/Control_2	Devices for lower limbs
Interventions/Control_3	Conventional training (Occupational therapy)
Interventions/Control_4	Conventional training (Physical therapy)
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Upper device 1. No pain in the shoulder and elbow joint 2. Patients with voluntary movement Lower device 1. A patients can stand up (partial assistance and no assistance)
Key exclusion criteria	1. Consciousness disorder 2. Severe aphasia and/or severe cognitive dysfunction
Target sample size	80

Research contact person
Name of lead principal investigator	Kiyomi Yoshioka
Organization	Meisei university
Division name	Department of Design
Address	2-1-1 Hodokubo, Hino, Tokyo
TEL	042-591-5111
Email	kiyomi.yoshioka@design.meisei-u.ac.jp

Public contact
Name of contact person	Hiroyuki Miyasaka
Organization	Fujita Health University Nanakuri Memorial Hospital
Division name	Division of Rehabilitation
Address	424-1 Oodori, Tsu, Mie
TEL	059-252-2744
Homepage URL
Email	hmiyasak@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Department of Design, Meisei university
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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 06 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 16 Day
Anticipated trial start date	2017 Year 06 Month 26 Day
Last follow-up date	2017 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 26 Day
Last modified on	2017 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030223