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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020927
Receipt No. R000023979
Scientific Title Examination of Constraint-induced movement therapy combining with transcranial Direct Current Stimulation and Peripheral Neuromuscular electrical stimulation
Date of disclosure of the study information 2016/05/31
Last modified on 2016/05/31

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Basic information
Public title Examination of Constraint-induced movement therapy combining with transcranial Direct Current Stimulation and Peripheral Neuromuscular electrical stimulation
Acronym Examination of Constraint-induced movement therapy combining with transcranial Direct Current Stimulation and Peripheral Neuromuscular electrical stimulation
Scientific Title Examination of Constraint-induced movement therapy combining with transcranial Direct Current Stimulation and Peripheral Neuromuscular electrical stimulation
Scientific Title:Acronym Examination of Constraint-induced movement therapy combining with transcranial Direct Current Stimulation and Peripheral Neuromuscular electrical stimulation
Region
Japan

Condition
Condition chronic stroke patients
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In Japan stroke affects nearly 1.3 million people annually, with over 30% of the patients experiencing some degree of permanent paralysis in upper extremity. Thus, the effective treatments need to be developed as soon as possible. Recently, the new nurorebalitation based on neuroscience have been developed such as constraint-induced movement therapy (CIMT) for post stroke upper extremity hemiplegia, and its efficacy has started to gather. However, there is not enough evidence on the functional improvement in chronic hemiplegia, and further intervention for post stroke hemiplegia is necessary. Therefore, to carry out stronger effect, we have combined CIMT which have the evidence level of grad A by AHA, transcranial Direct Current Stimulation (tDCS) which facilitate the plasticity of cerebral cortex, and peripheral electrical stimulation (PES). In this study, we conduct single-blinded randomized controlled trial (RCT) to compare the effectiveness of Hybrid CIMT (HCIMT: combination of CIMT with tDCS and PES) and usual CIMT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fugl-Meyer Assessment score for upper extremity
Key secondary outcomes Motor activity log Amount of use and quality of movement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients in Hybrid Constraint-induced movement therapy (HCIMT) group receives 4-hour transcranial Direct Current Stimulation (tDCS) and Peripheral Electrical stimulation (PES) before the therapy session: receive 20-minute tDCS and 10-minute PES before CIMT session. In the afternoon, they receive 20-minute tDCS and 10-minute PES, then 2-hour CIMT session. CIMT follows previous study (Takebayashi, et al,. Clini Reha 2013), where patients receive 4 hours of CIMT session per day for 10 days. The CIMT consist of three components: 1) concentrated training on hemiplegic arm, 2) task specific training, and 3) transfer package (translating the gain skill into their actual life). CIMT will be conducted by the trained occupational therapists. For tDCS, anode will be placed on the affect side of primary motor cortex, and cathode on the non-affected side of the primary motor cortex. Stimulus intensity would be 1mA. PES will target the extensor digitorum muscle, and stimulate. Stimulus intensity is below the threshold of muscle depolarization (approx. 3mA-5mA: adjusted to each subject), frequency at 20Hz, pulse width at 300micro second.
Interventions/Control_2 Patients in control group do not reviece any transcranial Direct Current Stimulation or Peripheral Electrical stimulation, and only receive 2-hour of Constraint-induced movement therapy (CIMT) in the morning and afternoon. CIMT follows previous study (Takebayashi, et al,. Clini Reha 2013), where patients receive 4 hours of CIMT session per day for 10 days. The CIMT consist of three components: 1) concentrated training on hemiplegic arm, 2) task specific training, and 3) transfer package (translating the gain skill into their actual life). CIMT will be conducted by the trained occupational therapists.
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria is as following: experienced their first stroke over 180 days ago. Motor function of shoulder and elbow joint must be over the stage IV in Brunnstrom recovery stage (BRS), and must have over 10 degree of MP joint and wrist extension.
Key exclusion criteria Exclusion criteria is as following: 1)cognitive problem (MMSE<25), 2)shoulder pain, 3)apraxia and aphasia.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Domen
Organization Hyogo college of medicine
Division name Department of Rehabilitation medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6388
Email takshi77@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Takebayashi
Organization Hospital of Hyogo college of medicine
Division name Department of rehabilitation
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6388
Homepage URL
Email takshi77@gmail.com

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Other
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
2016 Year 05 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 Open public recruiting
Date of protocol fixation
2014 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 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
2016 Year 02 Month 08 Day
Last modified on
2016 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023979

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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