The purpose of the present study was to investigate the efficiency of trans-cranial direct current stimulation (TDCS) application over the cerebellum region on postural stability in healthy older adults. This study has clinical trial design. Participants will be randomly allocated in two groups included; Group I who received 20 minutes TDCS over the cerebellum region and Group II who served as placebo group (mounted TDCS electrodes over the cerebellum region without any TDCS currents for 2 minutes). The healthy older participants with 60-75 years will be included. Participants who have history of neurological diseases or musculoskeletal disorders, severe perceptual and memorial problems, brain diseases, visual and auditory problems, lower extremity pathology and range of motion limitation will be excluded. All participants will be asked to stand on each static and dynamic level of Byodex Balance System platform for 30-second, before and after receiving TDSC treatment. Accordingly, the anterior/posterior, medial/lateral and overall stability indexes will be analyzed before and after TDCS treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010121294N3
Registration date:2016-04-03, 1395/01/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-04-03, 1395/01/15
Registrant information
Name
Fatemeh Ehsani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
f.ehsani@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences, Semnan, Iran
Expected recruitment start date
2016-04-30, 1395/02/11
Expected recruitment end date
2016-09-30, 1395/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cerebellum trans-cranial direct current stimulation (tDCS) on static and dynamic postural stability in older adult individuals
Public title
The effect of cerebellum trans-cranial direct current stimulation (tDCS) on postural stability in older adult individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Participants who have 60-75 years old will be concluded. Exclusion criteria: Participants had no history of neurological diseases or musculoskeletal disorders; Adults with severe perceptual and memory problems evidenced by Mini Mental Status Examination (MMSE) scores of less than 21; having neurological disease, especially Parkinson and Alzheimer's; having visual or auditory problems; having lower extremity pathology and range of motion limitations will be excluded from the study.
Age
From 60 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics commitie of Semnan university of medical science
Street address
5 kilometer in Damghan Road, Semnan Iran
City
Semnan
Postal code
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.SEMUMS.REC.1394.189
Health conditions studied
1
Description of health condition studied
healthy older adults
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Static stability indexes
Timepoint
Before and after receiving TDCS intervention
Method of measurement
Byodex Balance System
Secondary outcomes
1
Description
Dynamic postural indexes
Timepoint
Before and after receiving TDCS
Method of measurement
Byodex Balance System
Intervention groups
1
Description
Intervention group: Before and after receiving TDCS intervention, the participants will be asked to stand on static and dynamic levels of Byodex Balance System for 30-second. In TDCS intervention, anodal and cathodal electrodes will be positioned on cerebellum and ipsi-lateral deltoid muscle, respectively. Stimulation will be used with 2 Mili Ampere intensity for 20-minute.
Category
Rehabilitation
2
Description
Control group: Before and after receiving sham-TDCS intervention, the participants will be asked to stand on static and dynamic levels of Byodex Balance System for 30-second. In sham-TDCS intervention, anodal and cathodal electrodes will be positioned on cerebellum and ipsi-lateral deltoid muscle, respectively. Stimulation will be used with 2 Mili Ampere intensity for 2-minute.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Blvd. Ghods, Mashahir Square, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidipoor
Street address
Vice Chancellor for research of Semnan University of Medical Sciences, Blvd. Basig, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Semnan University 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
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Position
PhD., PT, Associate Professor
Other areas of specialty/work
Street address
Mashahir Square, Blvd. Ghods, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
f.ehsani59@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Position
Ph.D.
Other areas of specialty/work
Street address
Mashahir Square, Blvd. Ghods, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
f.ehsani@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Position
Ph.D., PT, Associate Professor
Other areas of specialty/work
Street address
Blvd. Ghods, Mashahir Square, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
f.ehsani@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)