UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043765 |
|---|---|
| Receipt number | 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 | 2024/03/31 10:19:33 |
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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
| 100 | years-old | > |
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
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 and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
5698686
Address
2-7,Daigaku-machi,Takatsuki,Osaka
TEL
072-683-1221
riku08070401@gmail.com
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Ishida |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
5698686
Address
2-7,Daigaku-machi,Takatsuki,Osaka
TEL
072-683-1221
Homepage URL
riku08070401@gmail.com
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
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 and Pharmaceutical University
Address
2-7,Daigaku-machi,Takatsuki,Osaka
Tel
072-683-1221
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
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049959
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
