UMIN-CTR Clinical Trial

Basic information
Public title	Effects of functional recovery treatments on hemiplegic upper/lower extremity of stroke patients
Acronym	Functional recovery treatments for hemiplegic upper/lower extremity
Scientific Title	Effects of functional recovery treatments on hemiplegic upper/lower extremity of stroke patients
Scientific Title:Acronym	Functional recovery treatments for hemiplegic upper/lower extremity
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of robot aided training on upper limb function, and neuromuscular electrical stimulation or safety harness gait training on lower limb function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl Meyer Assessment Active Range of Motion Functional Independence Measure Functional Gait Assessment
Key secondary outcomes	Stroke Impairment Assessment Set Functional Skills Measure After Paralysis Modified Ashworth Scale Motor Activity Log Wolf Motor Function Test Motion Analysis Simple Test for Evaluating Hand Function Berg Balance Scale Timed Up and Go Test Stabilometry Muscle Strength Muscle Cross-sectional area

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Robot aided training
Interventions/Control_2	Neuromuscular electrical stimulation
Interventions/Control_3	Safety harness gait training
Interventions/Control_4	Conventional training
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Comorbidity index of 3 or lower 2. First-ever hemiplegia with unilateral supratentorial legion 3. A patient who can understand the purpose of this study
Key exclusion criteria	1. Consciousness disorder 2. Severe aphasia and/or severe cognitive dysfunction 3. Intracranial metallic implant or pacemakers
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shigeru Middle name Last name SONODA
Organization	Fujita Health University
Division name	School of Medicine
Zip code	514-1295
Address	424-1 Oodoricho, Tsu, Mie 514-1296, Japan
TEL	059-252-1555
Email	doctor.sonoda@nifty.ne.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name MIYASAKA
Organization	Fujita Health University
Division name	Nanakuri Memorial Hospital
Zip code	514-1295
Address	424-1 Oodoricho, Tsu, Mie 514-1296, Japan
TEL	059-252-3138
Homepage URL
Email	hmiyasak@fujita-hu.ac.jp

Sponsor
Institute	Department of Rehabilitation Medicine II, School of Medicine, Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Fujita Health University Ceitified Review Board
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
Tel	0562-93-2865
Email	f-irb@fujita-hu.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	藤田医科大学七栗記念病院（三重県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 31 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	No longer recruiting
Date of protocol fixation	2015 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 01 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	2015 Year 07 Month 27 Day
Last modified on	2020 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021353