UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019805
Receipt number R000022829
Scientific Title A study on the effect of rehabilitative intervention on childhood cancer during and after treatment
Date of disclosure of the study information 2015/11/30
Last modified on 2020/06/02 10:33:38

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Basic information

Public title

A study on the effect of rehabilitative intervention on childhood cancer during and after treatment

Acronym

Effective rehabilitation for children with cancer

Scientific Title

A study on the effect of rehabilitative intervention on childhood cancer during and after treatment

Scientific Title:Acronym

Effective rehabilitation for children with cancer

Region

Japan


Condition

Condition

childhood cencer

Classification by specialty

Pediatrics Rehabilitation medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the period of effective rehabilitation intervention for pediatric cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Six-minute walk test: before and after cancer therapy, then after one year

Key secondary outcomes

Grip strength; Knee extension strength; One leg stand test; Timed up and go test; New physical fitness test of Japanese MEXT; Wechsler intelligence scale; Functional independence measure/functional assessment measure; Pediatric quality of life inventory; body composition; biochemical data; brain imaging


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Early rehabilitation (simultaneously with the start of cancer treatment)

Interventions/Control_2

Traditional rehabilitation (start from tapering phase of cancer treatment)

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

5 years-old <=

Age-upper limit

20 years-old >=

Gender

Male and Female

Key inclusion criteria

Children with cancer
Cancer therapy and hospitalization

Key exclusion criteria

Severe developmental disorder
Communication disorder
Astasia-abasia
Severe exercise-induced asthma
The terminal phase of the disease

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuma Sonoda

Organization

Shiga University of Medical Science Hospital

Division name

Rehabilitation Units

Zip code


Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2670

Email

yuma@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuma Sonoda

Organization

Shiga University of Medical Science Hospital

Division name

Rehabilitation Units

Zip code


Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2670

Homepage URL


Email

yuma@belle.shiga-med.ac.jp


Sponsor or person

Institute

Rehabilitation Units, Shiga University of Medical Science Hospital

Institute

Department

Personal name



Funding Source

Organization

Rehabilitation Units, Shiga University of Medical Science Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Pediatrics, Shiga University of Medical Science Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 11 Month 30 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

2015 Year 09 Month 29 Day

Date of IRB

2015 Year 09 Month 29 Day

Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date

2020 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

2015 Year 11 Month 16 Day

Last modified on

2020 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022829


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name