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Investigating and comparing the effect of brain training and balance training on the static and dynamic balance of the elderly individuals in nursing homes

Protocol summary

Study aim
Investigating and comparing the effects of brain exercises and balance exercises on the static and dynamic balance of elderly individuals in nursing homes
Design
This study is a clinical trial , without a control group, employing parallel groups, utilizing a blind strain, and employing an available sampling method, the sample size consist of 50 elderly individuals.
Settings and conduct
This study is conducted as a blind trial, meaning that the evaluator who assesses the study's outcomes and the results of both groups remains unaware of the group assignments. The study takes place in the physiotherapy department of the nursing home. Each group undergoes 12 sessions of 30 minutes. 1. The first group engages in balance exercises: Standing exercises, transfer exercises, walking exercises, functional strength exercises 2. The second group engages in brain exercises: lateralization; cross crawl, lazy eight, elephant, double doddle focalization; owl, lively arm, gravity glider, rocker centralization; brain button , earth button, balance button , space button, thinking cap
Participants/Inclusion and exclusion criteria
Elderly individuals aged 60 and above, residing in a nursing home, who are physically independent without any kind of disability according to ICF criteria; have not undergone surgery on the lower limbs and spine, and have no history of neurological diseases; do not have severe vision or hearing problems; and have given informed consent to participate in the study.
Intervention groups
1. The first group of balance exercises includes; standing exercises, transition exercises, walking exercises, functional strength exercises. 2. The second group of brain exercises includes; lateralization, focalization, concentration
Main outcome variables
Static Balance; Dynamic Balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210122050111N1
Registration date: 2023-07-03, 1402/04/12
Registration timing: prospective

Last update: 2023-07-03, 1402/04/12
Update count: 0
Registration date
2023-07-03, 1402/04/12
Registrant information
Name
Akramsadat Divandary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 1571
Email address
akramdivandari858@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the effect of brain training and balance training on the static and dynamic balance of the elderly individuals in nursing homes
Public title
Investigating and comparing the effect of brain training and balance training on the static and dynamic balance of the elderly individuals in nursing homes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years Ability to walk at least 9 meters without the assistance of another person or a cane Not engagment in regular exercise during the past year No physical disabilities of any kind (as per the World Health Organization's ICF definition of disability and based on medical opinions in the elderly file) No history of neurological disease including Parkinson's, Stroke and Multiple Sclerosis Absence of severe muscle and joint pain as per the doctor's opinion No dizziness and ability to cooperate during the research according to the doctor No history of surgery in the lower limbs and spine The absence of severe vision problems and significant hearing problems Informed consent to participate in the study
Exclusion criteria:
Withdrawal and dissatisfaction of participants from the research for any reason Physical injuries during the research Performing surgery on the lower limbs and spine Lack of informed consent to continue participating in any phase of the research
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who evaluates the outcome of the study and assesses the results obtained in both groups remains blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of University of Rehabilitation Sciences and Social Health
Street address
No. 5, Talghani Ave., Alame Tabatabei Ave., Alame Tababaei15 Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617695788
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.USWR.REC.1402.014

Health conditions studied

1

Description of health condition studied
Elder
ICD-10 code
F60.7
ICD-10 code description
Dependent personality disorder

2

Description of health condition studied
Static Balance
ICD-10 code
W18
ICD-10 code description
Other fall on same level

3

Description of health condition studied
Dynamic Balance
ICD-10 code
W17
ICD-10 code description
Other fall from one level to another

Primary outcomes

1

Description
Static balance
Timepoint
Static balance measurement is conducted at the beginning of the study (prior to the initiation of the intervention) and 30 days after the commencement of the exercise
Method of measurement
Single leg stance test

2

Description
Dynamic balance
Timepoint
Dynamic balance measurements at the beginning of the study (prior to the initiation of the intervention) and 30 days after the commencement of the exercise
Method of measurement
Time up and go test

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: balance exercises; 1. standing exercises 2. transitional exercises 3. walking exercises 4. functional strength exercises. twelve sessions of 30 minutes each.
Category
Rehabilitation

2

Description
The second intervention group: brain exercises; including; 1. lateralization: cross crawl, eight lazy, elephant, double duddle 2. focalization: owl, lively arm, gravity glider, rocker 3. centralization: brain button, earth button , balance button, space button, thinking cap. twelve sessions of 30 minutes each.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Mader Sabzevar Comprehensive Elderly Center Charity Foundation
Full name of responsible person
Mehdi Zabiholahi
Street address
No. 28, Aboreyhan bironi Ave, 22Bahman Ave , Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613944986
Phone
+98 51 4423 8801
Email
maryam.memarzade@gmail.com

2

Recruitment center
Name of recruitment center
Hazrat Abulfazl al-Abbas charity institution
Full name of responsible person
Mohammad Hossein Hadavifar
Street address
Salhabad, Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9615139958
Phone
+98 51 4420 1040
Email
salmandan.pedar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khanke
Street address
Koodakyar Ally., Daneshjo Blvd., Velenjak Qtr., Tehran Town
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
webmaster@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Sadat Divandari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 5, Talghani Ave., Alame Tabatabei Ave., Alame Tababaei15 Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617695788
Phone
+98 51 4464 1975
Email
akramdivandari858@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Sadat Divandari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 5, Talghani Ave., Alame Tabatabei Ave., Alame Tababaei15 Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617695788
Phone
+98 51 4464 1975
Email
akramdivandari858@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Sadat Divandari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 5, Talghani Ave., Alame Tabatabei Ave., Alame Tababaei15 Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617695788
Phone
+98 51 4464 1975
Email
akramdivandari858@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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