Peripheral neuropathy is a common complaint of diabetes. Peripheral neural damage in turn will cause balance impairments in diabetic patients. Diabetic neuropathy plays a significant role in falling among elderly patients, people with peripheral neuropathy caused by diabetes often experience balance disorder. Postural sway in these patients is increased, especially with the eyes closed .Peripheral neuropathy caused by diabetes causes significantly impaired sensation in the feet, reducing patients’ ability to control their balance properly during daily activities. Poor balance can be due to proprioception impairment. Balance problems are also caused by movement-strategy impairment, biomechanical structural disorders, and disorientation. 34 patient with moderate to severe neuropathy (toronto scale>8) that confirmed with electrodiagnosis are divided accidently into two group. All patient are examined for balance index with biodex balance system and berg balance scale questionnaire and then received physical therapy with IR and TENS for 30 minute 3 time in week. Intervention consists of 20 minute balance training with biodex balance system in ten sessions for 20 minute every session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211214641N6
Registration date:2012-12-05, 1391/09/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-05, 1391/09/15
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
physical medicine and rehabilitation research center
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ten sessions balance training on balance in diabetic neuropathy patient.
Public title
Effect of ten sessions balance training on balance in diabetic neuropathy patient.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 50 to70; confirmed diabetes type 2; moderate or severe diabetic neuropathy in toronto scale; peripheral neuropathy which confirmed with electrodiagnostic tests; the ability to stand independently, BMI less than 30. Exclusion criteria: diabetic ulcer; infection or partial amputation in feet; inability to stand independently; other diseases affecting balance; neurologic or orthopedic problem affecting balance; History of repeated ankle sprains in the year prior to the study; severe pain influencing balance; visual problems inability to see the stabilometer cursor; severe pain interfere with balance.
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz university of medical sciences
Street address
Golgasht Avenue
City
Tabriz
Postal code
Approval date
2012-10-29, 1391/08/08
Ethics committee reference number
91140
Health conditions studied
1
Description of health condition studied
Endocrine, nutritional and metabolic diseases
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
change in balance index with biodex balance system
Timepoint
before and after training
Method of measurement
Balance idex with biodex system
Secondary outcomes
1
Description
functional balance
Timepoint
befor and after training
Method of measurement
Berg balance scale
Intervention groups
1
Description
control :physical therapy(IR and TENS )
Category
Rehabilitation
2
Description
intervention: 10 session balance training with biodex balance system with physical therapy(IR and TENS )
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Mis Poorahmadian
Street address
Physical medicine and rehabilitation research center, Emam Reza hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical medicine and rehabilitation research center
Full name of responsible person
Dr. Seyed Kazem Shakouri
Street address
Emam Reza Hospital, Golgasht avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical medicine and rehabilitation research center
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
Tabriz university of medical sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associated professor-Physiatrist
Other areas of specialty/work
Street address
Tabriz university of medical sciences, Golgasht avenue
City
Tabriz
Postal code
Phone
+98 41 1336 1928
Fax
Email
binasadat@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associated professor-Physiatrist
Other areas of specialty/work
Street address
Tabriz university of medical sciences, Golgasht st
City
Tabriz
Postal code
Phone
+98 41 1336 1928
Fax
Email
binasadat@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roghaye Azizi
Position
Physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
azizidr@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)