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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039715
Receipt No. R000039872
Scientific Title Feasibility, safety, and efficacy of pediatric constraint-induced movement therapy for patients with upper extremity hemiparesis
Date of disclosure of the study information 2020/03/06
Last modified on 2020/03/05

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Basic information
Public title Feasibility, safety, and efficacy of pediatric constraint-induced movement therapy for patients with upper extremity hemiparesis
Acronym Pediatric constraint-induced movement therapy
Scientific Title Feasibility, safety, and efficacy of pediatric constraint-induced movement therapy for patients with upper extremity hemiparesis
Scientific Title:Acronym Pediatric constraint-induced movement therapy
Region
Japan

Condition
Condition Patients with upper extremity hemiparesis due to
cerebral palsy, stroke, brain tumor and traumatic brain injury.
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although recent studies showed that constraint-induced movement therapy (CIMT) is effective for pediatric patients with upper extremity hemiplegia, there are few studies in Japan. Therefore, there is a need to determine if the CIMT is effective in Japan. The purpose of this study is to evaluate the feasibility, safety, and effectiveness of CIMT for pediatric patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Outcome Measures
1) The feasibility of research protocol
2) Adverse events
3) Jebsen Taylor Test of Hand Function Test

Assessment timing
Outcome measures were assessed at baseline, after intervention, 1 month follow up, 6 months follow up and 12 months follow up.

Statistical assessment
Short-term effect: t test or Wilcoxon signed rank test
Long-term effect: ANOVA or Kruskal-Wallis or Dunnet Tukey-Kramer,or Bonferroni method
Key secondary outcomes (1) Fugl-Meyer Assessment
(2) Pediatric Motor Activity Log-Revised

Assessment timing
Outcome measures were assessed at baseline, after intervention, 1 month follow up, 6 months follow up and 12 months follow up.

Statistical assessment
Short-term effect: t test or Wilcoxon signed rank test
Long-term effect: ANOVA or Kruskal-Wallis or Dunnet Tukey-Kramer,or Bonferroni method

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intervention Technique: CIMT

Training Dose: more than 30 hours

Training Period: 3 Months

CIMT components: 1) constraining the patient to use the more-impaired UE, 2) repetitive, task-oriented training of the more-impaired UE, 3) transfer package (translating the gains made in the laboratory into the patient's real-world environment).
Interventions/Control_2
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

Not applicable
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria Patient with cerebral palsy
1) Gross Motor Function Classification System: 1-3
2) Manual ability classification system: 1-4

Other patients
1) Possible to walk independently
2) Brunnstrom recovery stage: 3-6
Key exclusion criteria 1) Unable to understand simple order
2) Uncontrolled complications
3) Unable to obtain informed consent
Target sample size 22

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Domen
Organization Hyogo college of medicine
Division name Department of rehabilitation medicine
Zip code 663-8501
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6111
Email umejiume@hyo-med.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Umeji
Organization Hyogo college of medicine college hospital
Division name Department of physical medicine and rehabilitation
Zip code 663-8501
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6388
Homepage URL
Email umejiume@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Hyogo college of medicine
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel 0798-45-6111
Email umejiume@hyo-med.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

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 06 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
2019 Year 02 Month 12 Day
Date of IRB
2019 Year 02 Month 12 Day
Anticipated trial start date
2019 Year 02 Month 12 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 05 Day
Last modified on
2020 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039872

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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