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The immediate and long-term effect of cerebellar anodal trans-cranial direct current stimulation (a-tDCS) on balance, static and dynamic postural stability in older adults with a high risk for falling

Protocol summary

Summary
The purpose of the present study was to investigate the immediate and long-term effect of cerebellar anodal trans-cranial direct current stimulation (a-tDCS) on balance and postural stability in older adults with high risk for falling. This study has clinical trial design. Participants will be randomly allocated in two groups included; Group I who received 20 minutes a-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 participants with 60-75 years and high risk for falling 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 (BBS) platform for 30-second, before and after receiving a-tDSC treatment. Accordingly, the anterior/posterior, medial/lateral and overall stability indices will be analyzed before and after a-tDCS treatment. ]n addition, before, after intervention and for one-week following, the falling sensation, stability indices and balance will be assessed by fall risk assessment tool, BBS and Berg balance scale, respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101021294N4
Registration date: 2017-02-10, 1395/11/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-10, 1395/11/22
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 of Semnan University of Medical Sciences
Expected recruitment start date
2016-12-31, 1395/10/11
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate and long-term effect of cerebellar anodal trans-cranial direct current stimulation (a-tDCS) on balance, static and dynamic postural stability in older adults with a high risk for falling
Public title
The immediate and long-term effect of cerebellar anodal trans-cranial direct current stimulation (a-tDCS) on balance, static and dynamic postural stability in older adults with a high risk for falling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Participants who have 60-75 years old and older adults who are prone to falling based on fall risk assessment tool or having falling history during 6 last month will be concluded. Exclusion criteria: Adults were no high risk for falling; 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 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
2016-08-10, 1395/05/20
Ethics committee reference number
IR.Semums.REC.1395.159

Health conditions studied

1

Description of health condition studied
Immediate and long-term effect of cerebellar anodal trans-cranial direct current stimulation on balance and psotural stability older adults with high risk for falling
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Static stability indices
Timepoint
Before receiving TDCS intervention, immediate and one-week after interventionafter
Method of measurement
Byodex Balance System

Secondary outcomes

1

Description
Dynamic postural indices
Timepoint
Before and after receiving TDCS, after one-week receiving TDCS
Method of measurement
Byodex Balance System

2

Description
Falling sensation
Timepoint
Before and after receiving TDCS, after one-week receiving TDCS
Method of measurement
Fall risk assessment tool

3

Description
Balance
Timepoint
Before and after receiving TDCS, after one-week receiving TDCS
Method of measurement
Berg balance scale

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
Placebo

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
Ali Rashidipoor
Street address
Vice Chancellor for research of Semnan University of Medical Sciences, Blvd. Basig
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
Assistant Professor
Other areas of specialty/work
Street address
Blvd. Ghods, Mashahir Square, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
fatemehehsani59@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
Assistant 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

Person responsible for updating data

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Position
Assistant Professor
Other areas of specialty/work
Street address
Blvd. Ghods, Mashahir Square, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
fatemehehsani59@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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