UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of Constraint-induced movement therapy combining with transcranial Direct Current Stimulation and Peripheral Neuromuscular electrical stimulation
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kazuhisa Domen
Organization	Hyogo college of medicine
Division name	Department of Rehabilitation medicine
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6388
Email	takshi77@gmail.com

Public contact
Name of contact person	Takashi Takebayashi
Organization	Hospital of Hyogo college of medicine
Division name	Department of rehabilitation
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 11 Month 01 Day
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

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Publication of results	Unpublished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