UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044410 |
|---|---|
| Receipt number | R000050731 |
| Scientific Title | Study on the learning effects in postural control using augmented sensory biofeedback training |
| Date of disclosure of the study information | 2021/06/03 |
| Last modified on | 2024/06/13 16:49:13 |
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Basic information
Public title
Study on the learning effects in postural control using augmented sensory biofeedback training
Acronym
Study on the learning effects in postural control using augmented sensory biofeedback training
Scientific Title
Study on the learning effects in postural control using augmented sensory biofeedback training
Scientific Title:Acronym
Study on the learning effects in postural control using augmented sensory biofeedback training
Region
| Japan |
Condition
Condition
Healthy adults, Older adults, People with neurological diseases
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the learning effects by using different augmented sensory biofeedback training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of pressure, Center of mass
Key secondary outcomes
Self-efficacy scale, Acceleration(Sway area, Velocity, Root mean square), Gait parameter(Velocity, Stride length, Foot strike angle, Cadence), Limits of stability, Cognitive function
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Auditory biofeedback training
60sec/trial, 16 blocks, 8 blocks/day, 2 days
Interventions/Control_2
Visual biofeedback training
60sec/trial, 16 blocks, 8 blocks/day, 2 days
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
Give a written informed consent to the participation in the present study
Key exclusion criteria
1.Suspected of severe dementia
2.Have a problem with the safe implementation of exercise
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Hasegawa |
Organization
Hokkaido University
Division name
Department of Rehabilitation Science, Faculty of Health Sciences
Zip code
060-0812
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-3531
n_hasegwa@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Naoya |
Organization
Hokkaido University
Division name
Department of Rehabilitation Science, Faculty of Health Sciences
Zip code
060-0812
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-3531
Homepage URL
n_hasegwa@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University, Department of Rehabilitation Science, Faculty of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University, Department of Rehabilitation Science, Faculty of Health Sciences
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
Tel
011-706-3316
shomu@hs.hokudai.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
北海道大学大学院保健科学研究院（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 03 | 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
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 08 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | 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 | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050731
