The purpose of this study is the assessment of mental practice on balance and sustained attention in elderly men (60-80yrs). This is a Randomized Controlled Trial (RCT) study, single blind , and carried out on 44 elderly men. The volunteers were assigned in two control and experimental (Mental Practice) groups after the initial assessment using a random block method. The balances of all the elderly during the 4 different phases were assessed using functional balance tests (six-minute walk Test and Timed Get up & Go, Berg Balance Scale). The balance assessments will be performed before and at the beginning of the intervention (initial assessment), immediately after the end of the intervention (post-treatment assessment) , Two weeks after the end of intervention (Short-term follow-up) and 3 months after the end of intervention (long-term follow-up).In addition, The assessments of sustained attention will be done by using Persian form of continuous performance test( CPT) software Test; before the beginning the intervention (initial assessment), 2 Weeks after the beginning of the intervention, immediately after the end of the intervention (post-treatment assessment) , Two weeks after the end of intervention (Short-term follow-up) and 3 months after the end of intervention (long-term follow-up). The treatment period is 3 days a week and will lasts 4 weeks. During this time, the elderly in the trial group will be treated by mental practice intervention.The period of treatment intervention is 15 minutes and will be performed as following: a relaxing excercises and thereafter mental Exe. (5 minutes and 10 minutes respectively).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201121722N4
Registration date:2012-06-10, 1391/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-10, 1391/03/21
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences (TUMS)
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of mental practice on balance and sustained attention in eldery men (60-80yrs)
Public title
The assessment of mental practice on balance and sustained attention in eldery men (60-80yrs)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Ages 60-80 years old; ability to read and write; Interest to participate in the research; The mean of rank as a result of two questionnaires of VVIQ and VMIQ for the assessment of capability of mental imaging less than 3/5 (Cook-Shumway, 2001); Berg's balance test screen less than 45, meaning there is a risk of falling for the elderly (fear of falling) Perell, 2001; Teresa, 2002; Susan, 2008 and Scott, 2007);The elderly has, at least, fallen once during the past 6 months; The elderly must have complete sight and hearing or one correctable with aids. Those with incorrectable insufficiencies wili not be included; No specific neurological or orthopedic disease, this must be confirmmed by a nursing home doctor, as well as any other malignancy, fracture and orthopedic side effects that might have negative effect on patient’s balance. It’s worth saying that ,here, by “ disease” , it dose not mean age- related side effects. 9) The elderly must obtain cognitive 's score of 22 or more in MMSE Test(Sayyedian, 2007); No adminstration of anti-psychotic, anti-convulsion drugs; Patients must not use walker, etc.
Exclusion Criteria: Any condition that interefer The participation of elderlies in the study; No interest of elderly for continiuing the research
Age
From 60 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Ethical committee of Tehran University of Medical Sciences (TUMS)
Street address
The Sixth Floor-Main Building of Tehran University of Medical Sciences-Ghods Str-Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2012-04-23, 1391/02/04
Ethics committee reference number
130/2687/د/90
Health conditions studied
1
Description of health condition studied
falling
ICD-10 code
w18
ICD-10 code description
Other fall on same level
2
Description of health condition studied
falling
ICD-10 code
w19
ICD-10 code description
Unspecified fall
3
Description of health condition studied
falling
ICD-10 code
w17
ICD-10 code description
Other fall from one level to another
4
Description of health condition studied
falling
ICD-10 code
w10
ICD-10 code description
Fall on and from stairs and steps
5
Description of health condition studied
falling
ICD-10 code
w01
ICD-10 code description
Fall on same level from slipping, tripping and stumbling
6
Description of health condition studied
falling
ICD-10 code
R29.6
ICD-10 code description
Tendency to fall, not elsewhere classified
7
Description of health condition studied
Senility
ICD-10 code
R54
ICD-10 code description
Senility
Primary outcomes
1
Description
balance
Timepoint
before the beginning the intervention (initial assessment), immediately after the end of the intervention (post-treatment assessment) , Two weeks after the end of intervention (Short-term follow-up) and 3 months after the end of intervention (long-term follow-up)
Method of measurement
Berg Balance Scale،Timed Get Up&GO، Six-Minute Walk Test
2
Description
sustained attention
Timepoint
before the beginning the intervention (initial assessment), 2 Weeks after the beginning of Intervention, immediately after the end of the intervention (post-treatment assessment) , Two weeks after the end of intervention (Short-term follow-up) and 3 months after the end of intervention (long-term follow-up)
Method of measurement
Persian form of CPT(continuous performance test) software
Secondary outcomes
empty
Intervention groups
1
Description
Performing the mental practice exe. as form of TUG test in the intervention group. The elderly will be asked to follow all the stages of TUG (as mental practice) as follows: sitting on a chair, then standing from the chair and go a 3-meters distance for reaching to a determined point. Then without any pause, the person should return to the chair. Afterward, it will be asked the person to do the task as much as faster with more skill.
Category
Rehabilitation
2
Description
During the intervention phase,the control group did not do certain exercises and just like the intervention group at the end of intervention phase Tests to assess balance and continuous performance test will be taken.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak Nursing homes
Full name of responsible person
Mr.Mohsen Pezeshki
Street address
Kahrizak Nursing Home -1 & 2 Banafsheh Block
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
postgraduate Studied and Research Program, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Jalili
Street address
The Seventh Floor- Main Building Tehran University of Medical Sciences-Ghods Str-Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
postgraduate Studied and Research Program, Tehran 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
Rehabilitation faculty, Tehran University of Medical Sciences
Full name of responsible person
Mehdi Karami
Position
M.Sc student of Occupational Therapy
Other areas of specialty/work
Street address
Rehabilitation faculty,pich e shemiran,enghlab street
City
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
Email
mehdiot@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences,TUMS
Full name of responsible person
Dr. Mohammad Reza Hadian
Position
Professor, Faculty of Rehabilitation, TUMS
Other areas of specialty/work
Street address
Rehabilitation faculty, pich e shemiran, enghlab street
City
Tehran
Postal code
Phone
+98 21 7753 6134
Fax
Email
hadianrs@sina.tums.ac.ir; hadian_ras@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rehabilitation faculty, Tehran University of Medical Sciences
Full name of responsible person
Mehdi Karami
Position
M.Sc student of Occupational Therapy
Other areas of specialty/work
Street address
Rehabilitation faculty,pich e shemiran,enghlab street
City
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
Email
mehdiot@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)