UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026345 |
|---|---|
| Receipt number | 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 09:28:41 |
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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
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
keisukedondon@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030180
