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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043765
Receipt No. R000049959
Scientific Title Changes in physical and cognitive function and activities of daily living in patients with brain tumor who receive multidisciplinary treatment
Date of disclosure of the study information 2021/03/27
Last modified on 2021/10/16

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Basic information
Public title Changes in physical and cognitive function and activities of daily living in patients with brain tumor who receive multidisciplinary treatment
Acronym Changes in physical and cognitive function and activities of daily living in patients with brain tumor who receive multidisciplinary treatment
Scientific Title Changes in physical and cognitive function and activities of daily living in patients with brain tumor who receive multidisciplinary treatment
Scientific Title:Acronym Changes in physical and cognitive function and activities of daily living in patients with brain tumor who receive multidisciplinary treatment
Region
Japan

Condition
Condition brain tumor
Classification by specialty
Neurosurgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1) To evaluate changes in physical and cognitive function and ADL in patients with brain tumor who receive rehabilitation treatment, radiation therapy, and chemotherapy after surgery through rehabilitation assessment.
2) To examine the relationship between physical and cognitive function and ADL in patients with brain tumors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Independence Measure
Key secondary outcomes Fugl-Meyer Assessment of Motor Recovery after Stroke
Isometric lower limb muscle strength
Stabilometry
10m walk test
Trunk Impairment Scale
The Postural Assessment Scale for Stroke Patients
Functional Gait Assessment
modified Rankin Scale
Functional Ambulation Categories Clas
Sification
Action Research Arm Test
Grip strength
EORTC QLQ-C30
BN-20
Mini-Mental State Examination
Trail Making Test
Digit Span
Line bisection test
Aphasia test

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Therapists (physiotherapist, occupational therapist, and speech therapist) conduct various rehabilitation measures for patients with brain tumor before and after surgery, radiotherapy, and chemotherapy. Examination by each therapist takes 40-60minutes.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with brain tumor who are admitted to the hospital and receive the rehabilitation treatment
Key exclusion criteria Uninformed patients
Lack of understanding and cooperation in the execution of the task
Additional orthopedic disorders or pain interfering with movement
Any other case that the examiner decides to be inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Ishida
Organization Osaka Medical College Hospital
Division name Department of Rehabilitation
Zip code 5698686
Address 2-7,Daigaku-machi,Takatsuki,Osaka
TEL 072-683-1221
Email riku08070401@gmail.com

Public contact
Name of contact person
1st name Naoya
Middle name
Last name Ishida
Organization Osaka Medical College Hospital
Division name Department of Rehabilitation
Zip code 5698686
Address 2-7,Daigaku-machi,Takatsuki,Osaka
TEL 072-683-1221
Homepage URL
Email riku08070401@gmail.com

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of Osaka Medical College
Address 2-7,Daigaku-machi,Takatsuki,Osaka
Tel 072-683-1221
Email rinri@art.osaka-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
2021 Year 03 Month 27 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 Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 24 Day
Date of IRB
2021 Year 03 Month 02 Day
Anticipated trial start date
2021 Year 03 Month 29 Day
Last follow-up date
2026 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
2021 Year 03 Month 27 Day
Last modified on
2021 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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