UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053704 |
|---|---|
| Receipt number | R000061140 |
| Scientific Title | Wii rehabilitation can substitute a conventional physiotherapy in the patients with glioma a proof of concept study |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/26 05:10:20 |
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Basic information
Public title
Wii rehabilitation can substitute a conventional physiotherapy in the patients with glioma a proof of concept study
Acronym
Wii rehabilitation can substitute a conventional physiotherapy in the patients with glioma a proof of concept study
Scientific Title
Wii rehabilitation can substitute a conventional physiotherapy in the patients with glioma a proof of concept study
Scientific Title:Acronym
Wii rehabilitation can substitute a conventional physiotherapy in the patients with glioma a proof of concept study
Region
| Japan |
Condition
Condition
glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Nintendo Wii (Wii) is sometimes used in rehabilitation (rehabilitation) and is known to have certain training effects, but there are no reports on brain tumour patients as far as we can find. In the present study, we replaced a part of conventional physiotherapy (PT) for glioma patients with the Wii and investigated the differences in the effects on motor function and ADL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl meyer assessment (FMA), Short Physical Performance Battery (SPPB)
Assessment times are at the start and end of rehabilitation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients were selected according to the following criteria: patients with a diagnosis of glioma who were admitted to hospital for radiation and chemotherapy and who underwent rehabilitation intervention, patients with a stable general condition, patients with stable standing, and patients who could understand the instructions.
Key exclusion criteria
Exclusion criteria are patients with visual or auditory impairments that prevent them from seeing and hearing feedback clearly, patients with higher brain dysfunction such as apraxia or hemispatial neglect that affect compliance with the rehabilitation programme, and patients with other comorbidities that affect movement.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Syoichi |
| Middle name | |
| Last name | Tashiro |
Organization
Kyorin University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
181-8611
Address
Kyorin University Hospital 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
0422-47-5511
s-tashiro@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Sakamoto |
Organization
Kyorin University Hospital
Division name
Department of Rehabilitation
Zip code
181-8611
Address
Kyorin University Hospital 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
0422-47-5511
Homepage URL
h-sakamoto@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Hospital
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
Kyorin University Hospital
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
Tel
0422-47-5511
h-sakamoto@ks.kyorin-u.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
| 2024 | Year | 04 | Month | 01 | 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
10
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 | 08 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2024 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061140
