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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018442
Receipt No. R000021353
Scientific Title Effects of functional recovery treatments on hemiplegic upper/lower extremity of stroke patients
Date of disclosure of the study information 2015/07/31
Last modified on 2020/01/29

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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/ctr_e/ctr_view.cgi?recptno=R000021353

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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