The primary aim of this study is to investigate the possible effect of TENS on postural control in patients with diabetic neuropathy. Twenty eight patients participate in this study. Then, patients by using block randomization allocate in intervention and control group. The inclusion criteria are patients with diabetic neuropathy age 40-55 years old with score 7 or above 7 in mishigan questionnaire.The exclusion criteria are the history of lower limb surgery, muscluskeletal and neuromuscular disorder. All participants are recruited from referrals of Motahari diabet clinic in Shiraz. We performeTENS for both groups. Intervention group are positioned supine on a treatment bench; then,high frequency electrical stimulation with the duration of 250 µs and 100 HZ frequency through surface electrodes placed at both sides of knee bilaterally for 4 minutes at sensory level. In control group, protocol are done like to intervention group but they receive sham electrical stimulation. postural control assess befoe, immediately and 15 and 30 minute after of the TENS application. we expect that TENS improve postural control in diabetic neuropathic patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304062391N10
Registration date:2014-07-18, 1393/04/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-18, 1393/04/27
Registrant information
Name
Zahra Rojhani Shirazi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1552
Email address
rojhaniz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rehabilitation Faculty- Shiraz Univercity of Medical Science
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2014-01-01, 1392/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of sensory electrical stimulation on postural control in diabetic neuropathy patients
Public title
Еffects of electrical stimulation on postural control
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: diabetic neuropathic patient 40-55 years old; Michigan Neuropathy Screening Instrument (MNSI) patient questionnaire 7 or above 7; MNSI above 2
exclusion criteria:fracture; dislocation; soft tissue injuries in lower extremities in 6 month ago; history of surgery in lower extremities; ankle or knee pain in test day; muscoloskletal and neuromuscular disorder like RA and myopathy; knee flexion contracture; use of walking aids;inner ear and vestibular system problems; regular exerciseing
Age
From 40 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
School of Rehabilitation Sciences, Chamran Boulevard, Abiverdi Street
City
Shiraz
Postal code
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
91/436616
2
Ethics committee
Name of ethics committee
Shiraz Univercity of Medical Science
Street address
Chamran Boulevard, Abiverdi Street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
91/436616
Health conditions studied
1
Description of health condition studied
Diabetic Polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic Polyneuropathy
Primary outcomes
1
Description
Balance
Timepoint
Immediately after interventio,15 and 30 min after interventio
Method of measurement
By forcplate
2
Description
Balance
Timepoint
Immediately, after 15 and 30 min of stimulation using
Method of measurement
Force plate
Secondary outcomes
empty
Intervention groups
1
Description
high frequency electrical stimulation( high frequency TENS with the duration of 250 µs and 100 HZ frequency) Intervention group are positioned supine on a treatment bench; then, electrical stimulation applies via an surface electrical stimulations places through surface electrodes placed at both side of knee bilaterally for 4 minutes at sensory level.
Category
N/A
2
Description
high frequency electrical stimulation( high frequency TENS with the duration of 250 µs and 100 HZ frequency) control group are positioned supine on a treatment bench; then,sham electrical stimulation applies via an surface electrical stimulations places through surface electrodes placed at both side of knee bilaterally for 4 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Diabetes Clinic
Full name of responsible person
Zahra Rojhani Shirazi
Street address
Faculty of Rehabilitation Sciences,Chamran Boulevard, Abiverdi Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Univercity of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Shiraz University of Medical Sciences, Shiraz, Fars
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Univercity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz Univercity of Medical Sience
Full name of responsible person
Dr. Zahra Rojhani Shirazi
Position
Asistant Professor
Other areas of specialty/work
Street address
Chamran Boulevard, Abiverdi 1 Street
City
Shiraz
Postal code
Phone
+98 71 1627 1551
Fax
Email
rojhaniz@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Univercity of Medical Sience
Full name of responsible person
Dr. Zahra Rojhani Shirazi
Position
Assistant Professor
Other areas of specialty/work
Street address
Chamran Boulevard, Abiverdi 1 Street
City
Shiraz
Postal code
Phone
+98 71 1627 1551
Fax
Email
rojhaniz@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rojhani Shirazi
Position
PHD
Other areas of specialty/work
Street address
School of Rehabilitation Sciences,Chamran Boulevard, Abiverdi Street
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
+98 71 1627 2495
Email
rojhaniz@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)