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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046116
Receipt No. R000050052
Scientific Title Effects of Exercise Instruction Using Sound Stimulation on gait Function and Foot Pressure in Patients with Diabetic Peripheral Neuropathy.
Date of disclosure of the study information 2021/11/18
Last modified on 2021/11/18

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Basic information
Public title Effects of Exercise Instruction Using Sound Stimulation on gait Function and Foot Pressure in Patients with Diabetic Peripheral Neuropathy.
Acronym Effect of exercise with sound stimulation on foot pressure in patients with DPN.
Scientific Title Effects of Exercise Instruction Using Sound Stimulation on gait Function and Foot Pressure in Patients with Diabetic Peripheral Neuropathy.
Scientific Title:Acronym Effect of exercise with sound stimulation on foot pressure in patients with DPN.
Region
Japan

Condition
Condition diabetic peripheral neuropathy
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine whether slow-tempo RAS intervention affects gait stability and foot pressure in DPN patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes foot pressure
Key secondary outcomes gait stability
gait speed
step length
cadence

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom Maneuver
Interventions/Control_1 The RAS group will perform walking exercise with slow-tempo auditory stimulation for one week in addition to normal rehabilitation. Auditory stimuli will be intervened at a tempo 10% slower than normal.
Interventions/Control_2 The control group is usual rehabilitation. The control group does not use auditory stimulation and the amount of walking is the same as the RAS group.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criteria are as follows: the ability to walk independently without assistance, hearing capacity sufficient to perceive the auditory cues, and the absence of significant cognitive impairment.
Key exclusion criteria Exclusion criteria included if they were pregnancy, taking corticosteroids, hormone replacement therapy, osteoporosis, chronic renal failure, chronic heart failure, current bilateral foot ulceration, severe retinopathy, neuropathic pain, malignancy, and endocrine disorders (other than diabetes).
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Keisuke
Middle name
Last name Suzuki
Organization Gifu University of Health Sciences
Division name Department of physical Therapy, Faculty of Rehabilitation
Zip code 500-8281
Address 2-92 Higashiuzura, Gigu, Gifu 500-8281, japan
TEL 058-274-5001
Email keisukedondon@gmail.com

Public contact
Name of contact person
1st name Keisuke
Middle name
Last name Suzuki
Organization Gifu University of Health Sciences
Division name Department of physical Therapy, Faculty of Rehabilitation
Zip code 500-8281
Address 2-92 Higashiuzura, Gigu, Gifu 500-8281, japan
TEL 058-274-5001
Homepage URL
Email keisukedondon@gmail.com

Sponsor
Institute Gifu University of Health Sciences
Institute
Department

Funding Source
Organization Ministry of Education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor International University of Health and Welfare Atami Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization International University of Health and Welfare
Address 2600-1, kitakanemaru, otawara, tochigi, japan
Tel 0287-24-3000
Email s-rinri@iuhw.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 国際医療福祉大学熱海病院

Other administrative information
Date of disclosure of the study information
2021 Year 11 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
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 Enrolling by invitation
Date of protocol fixation
2021 Year 02 Month 01 Day
Date of IRB
2021 Year 01 Month 21 Day
Anticipated trial start date
2021 Year 04 Month 01 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

Management information
Registered date
2021 Year 11 Month 18 Day
Last modified on
2021 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050052

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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