UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039715 |
|---|---|
| Receipt number | 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 18:21:58 |
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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
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
umejiume@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039872
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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