UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045022 |
|---|---|
| Receipt number | R000051427 |
| Scientific Title | Survey study using questionnaire on the effect of discontinuation of outpatient rehabilitation associated with COVID-19 in patients with SMID and children with cerebral palsy |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2021/09/25 17:41:57 |
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Basic information
Public title
Survey study using questionnaire on the effect of discontinuation of outpatient rehabilitation associated with COVID-19 in patients with SMID and children with cerebral palsy
Acronym
Survey study using questionnaire on the effect of discontinuation of outpatient rehabilitation associated with COVID-19 in patients with SMID and children with cerebral palsy
Scientific Title
Survey study using questionnaire on the effect of discontinuation of outpatient rehabilitation associated with COVID-19 in patients with SMID and children with cerebral palsy
Scientific Title:Acronym
Survey study using questionnaire on the effect of discontinuation of outpatient rehabilitation associated with COVID-19 in patients with SMID and children with cerebral palsy
Region
| Japan |
Condition
Condition
patients with SMID and children with cerebral palsy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate whether long-term discontinuation of outpatient rehabilitation associated with COVID-19 affected critically ill and CP children. As a result, the importance of outpatient rehabilitation including physical therapy for critically ill children and CP children will be clarified.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Likert scale
Key secondary outcomes
Gross motor function classification syste
Yokochi's classification
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | months-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Those who have consented to participate in this study
(2) Those who have been conducting outpatient rehabilitation at least once a week for 3 months or more until the outpatient rehabilitation is discontinued.
(3) Those aged 0 to 60.
Key exclusion criteria
(1) Those who are judged to be unstable from the therapist in charge within the last 3 months when outpatient rehabilitation is discontinued.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
Hokuto Hospital
Division name
Department of Rehabilitation
Zip code
080-0833
Address
7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
TEL
0155-48-8000
hokutopt.takahashi@gmail.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
Hokuto Hospital
Division name
Department of Rehabilitation
Zip code
080-0833
Address
7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
TEL
0155-48-8000
Homepage URL
hokutopt.takahashi@gmail.com
Sponsor or person
Institute
Hokuto Hospital
Tokachi Rehabilitation Center
Institute
Department
Personal name
Funding Source
Organization
Hokuto Hospital
Tokachi Rehabilitation Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokuto Hospital
Address
7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
Tel
0155-48-8000
hokutopt.takahashi@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
97
Org. issuing International ID_1
Hokuto Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
社会医療法人北斗 十勝リハビリテーションセンター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | 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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2001 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 01 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051427
