UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046116 |
|---|---|
| Receipt number | 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 | 2023/05/22 14:23:58 |
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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
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
keisukedondon@gmail.com
Sponsor or person
Institute
Gifu University of Health Sciences
Institute
Department
Personal name
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
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
55
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 | 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
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050052
