UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of exercise with rhythmic auditory stimulation on gait function of patients with diabetic peripheral neuropathy : a randomised controlled trial.
Title of the study (Brief title)	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	Keisuke Suzuki
Organization	International University of Health and Welfare
Division name	Department of Physical Therapy, School of Health Science at Odawara
Address	1-2-25 Shiroyama, Odawara, Kanagawa 250-8588, japan
TEL	0465-21-6724
Email	keisukedondon@gmail.com

Public contact
Name of contact person	Keisuke Suzuki
Organization	International University of Health and Welfare
Division name	Department of Physical Therapy, School of Health Science at Odawara
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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