UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054700 |
|---|---|
| Receipt number | R000062511 |
| Scientific Title | Longitudinal Evaluation of Changes in Center of Gravity Sway in a Patient with Cerebellar Ataxia by Physical Therapy combined with Transcranial Direct Current Stimulation over the cerebellum |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/06/18 23:43:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Longitudinal Evaluation of Changes in Center of Gravity Sway in a Patient with Cerebellar Ataxia by Physical Therapy combined with Transcranial Direct Current Stimulation over the cerebellum
Acronym
Longitudinal Evaluation of Changes in Center of Gravity Sway in a Patient with Cerebellar Ataxia by Physical Therapy combined with Transcranial Direct Current Stimulation over the cerebellum
Scientific Title
Longitudinal Evaluation of Changes in Center of Gravity Sway in a Patient with Cerebellar Ataxia by Physical Therapy combined with Transcranial Direct Current Stimulation over the cerebellum
Scientific Title:Acronym
Longitudinal Evaluation of Changes in Center of Gravity Sway in a Patient with Cerebellar Ataxia by Physical Therapy combined with Transcranial Direct Current Stimulation over the cerebellum
Region
| Japan |
Condition
Condition
Cerebellar ataxia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to longitudinally evaluate the changes in center of gravity sway in a patient with cerebellar ataxia by physical therapy combined with transcranial direct current stimulation (tDCS) over the cerebellum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of gravity sway
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Physical therapy such as walking and postural balance rehabilitation combined with tDCS over the cerebellum
Interventions/Control_2
Physical therapy such as walking and postural balance rehabilitation
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cerebellar ataxia due to cerebellar hemorrhage or infarction who are admitted to the Rehabilitation Unit
Key exclusion criteria
(1) metal in the skull or eyes
(2) pacemaker or implanted pump in the body
(3) metal plate in the skull
(4) history of craniotomy
(5) skin disorders at the stimulation site
(6) history of epilepsy
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sato |
Organization
Kio university
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
yukicourage0917@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sato |
Organization
Kio university
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
yukicourage0917@gmail.com
Sponsor or person
Institute
Kio university
Institute
Department
Personal name
Yuki Sato
Funding Source
Organization
Kio university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
akarazuka Rehabilitation Hospital, Medical Corporation SHOWAKAI
Address
2-2 Tsurunoso, Takarazuka-shi, Hyogo
Tel
0797-81-2345
yukicourage0917@gmail.com
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 | 06 | Month | 18 | 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
1
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 | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062511
