Protocol summary

Study aim
to study the effect of the internal and external attention focus instructions and the dual task on static and dynamic balance in the elderlies
Design
Among 100 elderlies residing in Salehin Nursing Home, 40 participant will be selected and allocate them to 4 groups. pre-test will be carried out to measure the static and dynamic balance of subjects .The interventions include three 1 hour sessions in three consequent days and post-test will be carried out day after the intervention.
Settings and conduct
All subject will be recruited from Salehin Nursing Home which is a 24 houre mixed sex residential for elderlies located in Golestan Blvd., Ahvaz, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 65 to 80 years, normal vision, ability to stand for at least one minute and walking distance of 10 meters independently or with a regular cane, a score higher than 24 in the MMSE. Exclusion criteria: dependen inactivities daily , having neurological, psychological and atrial disorders, cognitive impairment, drug and drug usage, and having musculoskeletal disorders
Intervention groups
Four groups: internal attention focus (IAF), external attention focus (EAF), dual- task (DT) and control. each group 10 participants.
Main outcome variables
static and dynamic balance in elderly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180109038280N1
Registration date: 2018-11-05, 1397/08/14
Registration timing: retrospective

Last update: 2018-11-05, 1397/08/14
Update count: 0
Registration date
2018-11-05, 1397/08/14
Registrant information
Name
Ali Asghar Arastoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 2675
Email address
draarastoo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different instructions of attention focus and dual task on the static and dynamic balance of the inactive elderly
Public title
The effect of different attention instructions on the balance of the inactive elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
آaving normal vision, Lack of brain and orthopedic damages i The ability to stand at least for one minute and walking distance of 10 meters independently or with a regular cane, The ability to follow simple commands, Earning a score higher than 24 in the MMSE exam Age of 65 to 80 years
Exclusion criteria:
Lack of autonomy in activities of daily living Having a general health problem, Having neurological, psychological and atrial disorders based on medical diagnosis Reporting, cognitive impairment Having musculoskeletal disorders
Age
From 65 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
From a list of 100 elderlies residing in Ahvaz Salehin Nursing Home, 40 eligible individuals willing to participate, will be recruited through simple random sampling using /https://www.randomizer.org
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
AJUMS Campus, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6137515751
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
1396.741.IR.AJUMS.REC

Health conditions studied

1

Description of health condition studied
Elderlies residential of Salehin Nursing Home of Ahvaz, Iran
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Static and dynamic balance of inactive elderlies
Timepoint
Pre-test, 3 days task specific training course, post-test
Method of measurement
Time duration in seconds

Secondary outcomes

1

Description
]mprove or disruption of static and dynamic balance
Timepoint
One day after training of task specific intervention course
Method of measurement
Time duration in seconds

Intervention groups

1

Description
Intervention group 1: Internal attention focus (IAF). In the IAF group, the instruction was as follows: during static and dynamic balance, they were asked to look and focus on their legs.
Category
Rehabilitation

2

Description
Intervention group 2: External Attention Focus (EAF). In the EAF group, they were asked to look and focus to the end of the path during dynamic balance and concentrate on that point, and during their static balance, their attention should be to the outside and at a distance of 3 meters from themselves.
Category
Rehabilitation

3

Description
Intervention group 3: Dual Task (DT). In the DT group, the instruction was such a way that during a static and dynamic balance task, a simple secondary cognitive task (counting back of a series of randomly assigned numbers) was given to them.
Category
Rehabilitation

4

Description
Control group: Comparison. In the control group, no instructions were given.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Elderly Residential Salehin Nursing Home, Ahvaz, Iran
Full name of responsible person
Dr Ali Asghar Arastoo
Street address
Shahid Beheshti Ave (Kooye 22 Bahman), Golestan Boulevard)
City
Ahvaz
Province
Khouzestan
Postal code
61346-38185
Phone
+98 61 3339 4191
Fax
+98 21 4385 7842
Email
salehinngo@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badavi
Street address
AJUMS Campus, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6137515751
Phone
+98 61 3336 1984
Email
research@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Aghar Arastoo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
AJUMS Campus, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6137515751
Phone
+98 61 3336 2675
Email
aaarastoo@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
ِDr Ali Asghar Arastoo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
AJUMS Campus, Golestan, Blvd
City
ahvaz
Province
Khouzestan
Postal code
6137515751
Phone
+98 63 3373 8296
Email
draarastoo@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Shaid Chamran
Full name of responsible person
Sajad Parsaei
Position
Staff
Latest degree
Master
Other areas of specialty/work
Physical Education
Street address
No 3, Kooche haftom, kheirabad Blvd
City
Fasa
Province
Fars
Postal code
74661-53551
Phone
+98 715433931
Email
sajadparsaei@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
data related to the main outcome
When the data will become available and for how long
9 months after publication of the manuscript
To whom data/document is available
All the people interested to the field of elderly
Under which criteria data/document could be used
Statistical analysis and scientific, clinical and rehabilitation utilization
From where data/document is obtainable
Corresponding member
What processes are involved for a request to access data/document
Up to a duration of time that I have access to computer of data file. i.e. not to be in a journey
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