UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056203 |
|---|---|
| Receipt number | R000064221 |
| Scientific Title | Virtual Reality-guided rehabilitation for patients with chemotherapy-induced peripheral neuropathy |
| Date of disclosure of the study information | 2024/11/19 |
| Last modified on | 2026/02/22 16:37:40 |
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Basic information
Public title
Safety and feasibility of virtual reality-guided rehabilitation for chemotherapy-induced peripheral neuropathy.
Acronym
VR-guided rehabilitation for CIPN
Scientific Title
Virtual Reality-guided rehabilitation for patients with chemotherapy-induced peripheral neuropathy
Scientific Title:Acronym
VR-guided rehabilitation for CIPN
Region
| Japan |
Condition
Condition
chemotherapy-induced peripheral neuropathy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of virtual reality rehabilitation for patients with moderate to severe chemotherapy-induced peripheral neuropathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of VR-guided rehabilitation sessions and drop-out rates
Key secondary outcomes
neurological symptoms, physical function (grip strength, balance),participants perspective, adverse events.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who visited the cancer rehabilitation and locomotion outpatient clinic of the institution and underwent VR-guided rehabilitation for chemotherapy-induced peripheral neuropathy.
Key exclusion criteria
Individuals who have indicated their intention not to participate in the study.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Miyata |
Organization
NHO Tokyo Medical Center
Division name
Palliative care medicine and Caner rehabilitation
Zip code
152-8902
Address
Higashigaoka 2-5-1, Meguro-ku, Tokyo
TEL
0334110111
kuma1mie2chibi3@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Miyata |
Organization
NHO Tokyo Medical Center
Division name
Palliative care medicine and Cancer rehabilitation
Zip code
152-8902
Address
Higashigaoka 2-5-1, Meguro-ku, Tokyo
TEL
0334110111
Homepage URL
kuma1mie2chibi3@yahoo.co.jp
Sponsor or person
Institute
NHO Tokyo Medical Center
Institute
Department
Personal name
Chieko Miyata
Funding Source
Organization
Non
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
NHO Tokyo Medical Centre Ethics Committee
Address
Higashigaoka 2-5-1, Meguro-ku, Tokyo
Tel
0334110111
kuma1mie2chibi3@yahoo.co.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 | 11 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Paper submission in progress
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Retrospective cohort study. Methods of recruitment: individuals who visited our institution between August and October 2022 and met the selection criteria. Individuals who fulfilled the inclusion criteria. Primary endpoints: number of training sessions and drop-out rates, (reasons for drop-out). Secondary endpoints: pain and numbness status, physical function (Grip strength, balance).
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2026 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064221
