UMIN-CTR Clinical Trial

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

chronic stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Fugl-Meyer Assessment score for upper extremity

Key secondary outcomes

Motor activity log Amount of use and quality of movement

Study type

Interventional

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

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

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

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

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

Institute

Hyogo college of medicine

Institute

Department

Personal name

Organization

non

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

05

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

02

Month

08

Day

Last modified on

2016

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023979