Protocol summary
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Study aim
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The purpose of this study was to investigate the effect of neurofeedback and somatosensory training on balance and physical functional performance in healthy elderly adults.
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Design
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The design of applied research has consisted of a control group and two parallel groups so that after checking inclusion and exclusion criteria, 60subjects were selected as the sample and divided into three groups through the restricted randomization method.
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Settings and conduct
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this study was performed with the aim of prevention in Shahid Beheshti Hospital of Kerman. The recall for participation was carried out by informing all Kerman retirement centers and the Welfare organization.
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Participants/Inclusion and exclusion criteria
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The population of the study was men aged 60-70 in Kerman. the inclusion criterion was aged 60-70 and the Exclusion criteria were Scores above 9 on the general health questionnaire-28 and scores below 24 on the mini-mental state examination, Cardiovascular instability, metabolic diseases, recent unhealed fractures, Those who have a life of up to one year, excessive alcohol intake, and inability to speak.
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Intervention groups
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The two intervention groups performed their exercises 15 sessions, three sessions a week and each session for one hour. In the first group somatosensory training and in the second one somatosensory and neurofeedback training (30 minutes for each one), were performed. The control group did not receive any intervention during this period.
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Main outcome variables
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The main variables of the research were the balance and physical functional performance of the elderly. to evaluation each of them, the stork balance test, the timed up and go test and the physical functional performance were used.
General information
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Reason for update
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Since the desired research has not been conducted on the specified date and the project has been halted, recently, the researchers deem it necessary to update the experimental information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191201045568N1
Registration date:
2020-05-06, 1399/02/17
Registration timing:
prospective
Last update:
2024-05-06, 1403/02/17
Update count:
2
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Registration date
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2020-05-06, 1399/02/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-04, 1402/03/14
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Expected recruitment end date
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2023-07-20, 1402/04/29
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Actual recruitment start date
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2023-06-04, 1402/03/14
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Actual recruitment end date
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2023-07-20, 1402/04/29
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Trial completion date
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2023-07-20, 1402/04/29
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Scientific title
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Effect of neurofeedback and somatosensory training on balance and Physical Functional Performance in healthy elderly adults
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Public title
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Effect of neurofeedback and somatosensory training on balance and Physical Functional Performance in healthy elderly adults
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
people who were 60-70 years old.
Exclusion criteria:
People who have been in balance training for the past few months.
People who scored above 9 on the General Health Questionnaire(GHQ).
People who scored less than 24 on the Mini-Mental State Exam (MMSE)
People who have cardiovascular instability.
People who have metabolic diseases.
People who had recent unhealed fractures.
Those who couldn't speak.
People who have a life of up to one year.
People who were unable to follow directions.
People who intake excessive alcohol.
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Age
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From 60 years old to 70 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
75
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Initially, the general sample of the study was selected according to the inclusion and exclusion criteria and then divided into three groups through the restricted randomization method and the random allocation rule, using a sealed envelope for each individual.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The researchers are unaware of the participants' grouping in terms of examining and analyzing the results in the pre-test and post-test.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-22, 1398/09/01
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Ethics committee reference number
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IR.UK.VETMED.REC.1398.025
Health conditions studied
1
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Description of health condition studied
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balance and physical function performance in elderly adults
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Static Balance Score in stork balance Test
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Timepoint
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before intervention, Intermediate Test before Session Eight, after five weeks of intervention
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Method of measurement
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stork balance test
2
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Description
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dynamic balance score in timed up and go test
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Timepoint
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before intervention, Intermediate Test before Session Eight, after five weeks of intervention
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Method of measurement
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timed up and go test
3
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Description
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continuous-scale physical functional performance test(CS-PFP-10) score for measuring elderly ability in daily activities
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Timepoint
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before intervention and after five weeks of intervention
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Method of measurement
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The continuous-scale physical functional performance test(CS-PFP-10)
Secondary outcomes
1
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Description
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general health questionnaire-28 score (GHQ-28)
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Timepoint
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before intervention and after intervention
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Method of measurement
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general health questionnaire-28
2
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Description
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mini-mental state examination score
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Timepoint
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before intervention and after intervention
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Method of measurement
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mini-mental state examination(MMSE)
Intervention groups
1
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Description
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Control group:20 men aged 60-70 years old participated in the pre-test and did not receive any intervention, In the eighth session as a middle test were assessed only static and dynamic balance tests. finally, after five weeks, the subjects were evaluated in the post-test with static and dynamic balance tests and continuous-scale physical function performance test.
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Category
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Other
2
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Description
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first Intervention group: 20 men 60-70 years old in this group received Somatosensory training for 15 sessions, three sessions per week and each session for one hour. one hour of each session was divided into three periods as follows: warm-up with static and dynamic stretches (20 min), walk on a patterned surface (30 min) and cool down (10 min).
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Category
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Prevention
3
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Description
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This group consisted of 20 elderly men who underwent 15 sessions of neurofeedback and sensory-motor exercises. They had three sessions per week, with each session lasting one hour. The participants spent 30 minutes on neurofeedback exercises and 30 minutes on sensory-motor exercises.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Bahonar University
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Proportion provided by this source
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30
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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This data cannot be accessed under the laws of ethics and privacy act.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Some parts of information including main results will be shared only after making the participants unidentifiable.
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When the data will become available and for how long
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The start of the data access period will be immediately after printing the results.
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To whom data/document is available
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The data will be accessible to researchers, The elderly organizations and departments and also the journals.
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Under which criteria data/document could be used
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In order to assist scientific researches and advance executive goals with an approach to promote the level of independence and performance of the elderly
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From where data/document is obtainable
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sedighi.s@yahoo.com
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What processes are involved for a request to access data/document
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Requests for access to data will be answered within a week.
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Comments
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