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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026345
Receipt No. R000030180
Scientific Title Effect of exercise with rhythmic auditory stimulation on gait function of patients with diabetic peripheral neuropathy : a randomised controlled trial.
Date of disclosure of the study information 2017/03/01
Last modified on 2017/03/01

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Basic information
Public title Effect of exercise with rhythmic auditory stimulation on gait function of patients with diabetic peripheral neuropathy : a randomised controlled trial.
Acronym Effect of exercise with auditory stimulation on gait function of DPN patients.
Scientific Title Effect of exercise with rhythmic auditory stimulation on gait function of patients with diabetic peripheral neuropathy : a randomised controlled trial.
Scientific Title:Acronym Effect of exercise with auditory stimulation on gait function of DPN patients.
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 was to determine whether intervention using RAS affected the lower limb muscle coordination and gait performance of patients with DPN.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gait stability
Key secondary outcomes gait speed
step length
cadence
co-contraction

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 carries out gait exercise using rhythmic auditory stimulation in addition to usual rehabilitation.
Interventions/Control_2 The control group is usual rehabilitation.The control group did the same amount of walking as the RAS group, albeit without the rhythmic auditory stimulation.
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 were 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 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Suzuki
Organization International University of Health and Welfare
Division name Department of Physical Therapy, School of Health Science at Odawara
Zip code
Address 1-2-25 Shiroyama, Odawara, Kanagawa 250-8588, japan
TEL 0465-21-6724
Email keisukedondon@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Suzuki
Organization International University of Health and Welfare
Division name Department of Physical Therapy, School of Health Science at Odawara
Zip code
Address 1-2-25 Shiroyama, Odawara, Kanagawa 250-8588, japan
TEL 0465-21-6724
Homepage URL
Email keisukedondon@gmail.com

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Iwata City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 磐田市立総合病院(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 01 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 Completed
Date of protocol fixation
2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 01 Day
Last modified on
2017 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030180

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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