UMIN-CTR Clinical Trial

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

Type 2 Diabetes neuropathy

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tarbiat Modares University

Institute

Department

Personal name

Organization

Tarbiat Modares University

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

11

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

10

Month

31

Day

Last modified on

2010

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005302