UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020927 |
|---|---|
| Receipt number | 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 08:18:00 |
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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
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
takshi77@gmail.com
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023979
