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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004485
Receipt No. R000005302
Scientific Title Dynamic stability training can promote quiet standing control in neuropathic patients with type 2 diabetes
Date of disclosure of the study information 2010/11/06
Last modified on 2010/10/31

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Basic information
Public title Dynamic stability training can promote quiet standing control in neuropathic patients with type 2 diabetes
Acronym Dynamic stability training can promote quiet standing control in neuropathic patients with type 2 diabetes
Scientific Title Dynamic stability training can promote quiet standing control in neuropathic patients with type 2 diabetes
Scientific Title:Acronym Dynamic stability training can promote quiet standing control in neuropathic patients with type 2 diabetes
Region
Asia(except Japan)

Condition
Condition Type 2 Diabetes neuropathy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 context specific balance rehabilitation of type 2 diabetese neuropathic patients by provoking somatosensory information with respect to the guidance effect of external visual biofeedback
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Standing balance control scores were acquired from Biodex stability system and fluctuations of COP signals. Repeated measure ANOVA was performed to test mean differences and then compared with the LSD test. Paired T-test was used for comparing the pure effect of trainings. Our investigation showed statistical improvement in the results of Biodex stability scores and force platform mediolateral sway.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 In this study, there was a 3-week baseline with evaluation after 3 weeks (time effect) followed by training over 3 weeks with re-evaluation (training effect). First evaluation included descriptive information such as age, sex, height, weight, BMI, Valk score, diabetic history and postural strategy assessments by biodex stability scores (BSS) and force platform assessments. After the first 3-week, patients were evaluated for the second time by Valk score and postural strategy assessments. Third evaluation was again included Valk score and postural strategy assessments after the patients had been trained by biodex balance exercises in the second 3-week. In this study, force platform evaluations were included, in order to evaluate DN patients` postural strategy with the more precise assessment other than the device that they were trained with.
Interventions/Control_2
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
40 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients` neuropathies were assessed by nerve conduction velocity tests.Patient inclusion criteria included patient age (between 40-70 years old), duration of time suffering from controlled type 2 diabetes (more than 5 years. Patient FBS test results (greater than 110mg/dl), Valk neuropathy score (greater than 2) and Snellen chart score (greater than 16/20)
Key exclusion criteria Participants were excluded from this study if they had retinopathy, scars under their feet, BMI score greater than 40, hypotension, autonomic neuropathy and any orthopedic or neurologic impairment related to balance performance. And they were also excluded if they had prior experience of balance trainings with biodex stability system (BSS), force platform and the task
Target sample size 19

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hoda Salsabili
Organization Tarbiat Modares University
Division name Physiotherapy
Zip code
Address Jalal Al Ahmad Street, Gisha Bridge
TEL +81-098-021-77927852
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hoda Salsabili
Organization Tarbiat Modares University
Division name Physiotherapy
Zip code
Address Jalal Al Ahmad Street, Gisha Bridge
TEL +81-098-021-77927852
Homepage URL
Email h.salsabili@gmail.com

Sponsor
Institute Tarbiat Modares University
Institute
Department

Funding Source
Organization Tarbiat Modares University
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 06 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
2009 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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
2010 Year 10 Month 31 Day
Last modified on
2010 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005302

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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