UMIN-CTR Clinical Trial

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
Email	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
Email	hokutopt.takahashi@gmail.com

Sponsor
Institute	Hokuto Hospital Tokachi Rehabilitation Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051427