UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018442 |
|---|---|
| Receipt number | 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 11:40:51 |
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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
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
hmiyasak@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine II, School of Medicine, Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021353
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
