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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000044410
Receipt No. 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 2021/06/03

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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
20 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
Email 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
Email n_hasegwa@hs.hokudai.ac.jp

Sponsor
Institute Hokkaido University, Department of Rehabilitation Science, Faculty of Health Sciences
Institute
Department

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
Email 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 10
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 Suspended
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
2021 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050731

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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