UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041593
Receipt number R000047484
Scientific Title Factors effecting functional improvement associated with cranioplasty
Date of disclosure of the study information 2020/09/15
Last modified on 2022/02/28 13:50:23

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Basic information

Public title

Factors effecting functional improvement
associated with cranioplasty

Acronym

Factors effecting functional improvement
associated with cranioplasty

Scientific Title

Factors effecting functional improvement
associated with cranioplasty

Scientific Title:Acronym

Factors effecting functional improvement
associated with cranioplasty

Region

Japan


Condition

Condition

Brain injury/Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of factors effecting functional improvement associated with cranioplasty

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of factors effecting functional improvement associated with cranioplasty

Key secondary outcomes



Base

Study type

Observational


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

10 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who underwent craniotomy decompression at our hospital

Key exclusion criteria

Cases before starting an electronic medical record system

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Nobuyuki
Middle name
Last name Arai

Organization

Kawasaki Medical School

Division name

Department of Rehabilitation Medicine

Zip code

701-0192

Address

577 Matsushima, Kurashiki-shi, Okayama

TEL

086-462-1111

Email

dodobiyan@med.kasawasaki-m.ac.jp


Public contact

Name of contact person

1st name Nobuyuki
Middle name
Last name Arai

Organization

Kawasaki Medical School

Division name

Department of Rehabilitation Medicine

Zip code

701-0192

Address

577 Matsushima, Kurashiki-shi, Okayama

TEL

086-462-1111

Homepage URL


Email

dodobiyan@med.kasawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Nothing

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

Kawasaki Medical School

Address

577 Matsushima, Kurashiki-shi, Okayama

Tel

086-464-1164

Email

rinri@hp.kawasaki-m.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 09 Month 15 Day


Related information

URL releasing protocol

https://rinri-system.kawasaki-m.ac.jp/esct/publish_document.aspx?ID=1206

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/prm/7/0/7_20220008/_pdf/-char/en

Number of participants that the trial has enrolled

102

Results

Cases of trefine syndrome were significantly younger than those with non-trefin syndrome, and the number of days from cranectomy decompression to cranioplasty was shorter (P <0.05). In Trefin syndrome, the FIM motor score was greater than the improvement in cognitive score (P <0.05). In addition, the proportion of patients who underwent craniotomy with exacerbations within 48 hours after admission was higher in Trefine syndrome (P <0.05).

Results date posted

2022 Year 02 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients who underwent craniectomy at Kawasaki Medical School Hospital between January 1, 2010, and March 15, 2020, were included in this study.

Participant flow

The inclusion criterion was a modified Rankin Scale (mRS) score of 0 or 1 before illness. The exclusion criteria included changes in the drug regimen that could affect cognitive function, such as the main effects of psychotropic and nootropic drugs, a week before or after cranioplasty, and conditions, such as infection, that worsened the general condition of the patient 1 week before or after cranioplasty

Adverse events

None

Outcome measures

age, sex, causative disease, modified Rankin scale(mRS), date and time of onset of primary disease, Glasgow Coma Scale (GCS) score on acute admission, number of comorbidities, date and time of craniectomy decompression, date of cranioplasty, presence of complications before cranioplasty, materials used for cranioplasty, drugs used for the central nervous system, and the FIM score.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 03 Month 15 Day

Date of IRB

2020 Year 04 Month 08 Day

Anticipated trial start date

2020 Year 04 Month 08 Day

Last follow-up date

2020 Year 08 Month 08 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Prescription contents, medical record, therapist's record (physics, work, language hearing), nursing record, ex-chart, goat document, image record, test result, physiological test result, hospitalization date, discharge date, age, sex, Presence or absence of skull formation


Management information

Registered date

2020 Year 08 Month 28 Day

Last modified on

2022 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047484


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name