UMIN-CTR Clinical Trial

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