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The effectiveness of neurofeedback and cognitive rehabilitation on balance and cognitive function in the elderly

Protocol summary

Study aim
The effectiveness of neurofeedback and cognitive rehabilitation on balance and cognitive functions in the elderly
Design
A concealed, randomized trial with blinded data investigator. A total of 40 individuals were chosen, and then they were randomly divided into 3 groups: neurofeedback groups, cognitive rehabilitation treatments, combination of both and control group.
Settings and conduct
Before and after interventions, the balance of participants in all three groups was assessed using the Timed Up and Go test, the Berg Balance Scale, and the Tinetti balance score and cognitive function in each group was assessed using Mini-mental state examination and Montreal Cognitive Assessment. After neurofeedback training and Captain Log cognitive rehabilitation and combined them, post-test was taken from all four groups. The place of conducting the trial is the Movafaghiat Clinic. Data for all subjects were obtained, by an investigator who was blinded to the treatment allocation.
Participants/Inclusion and exclusion criteria
Those elderly 65-74 years old who are able to walk independently without assistive devices, do not have cranial implants and have no history of attending psychotherapy and neurofeedback sessions are recruited into this study. Subjects with a definite diagnosis of neurological disorders, orthopedic disorders and cardiovascular and respiratory diseases, as well as those who suffer from visual or vestibular impairment or take medications that cause balance disorders and, absent during intervention sessions, are excluded from the study
Intervention groups
Neurofeedback is a method that assists subjects to control their brain waves consciously. The intervention in the cognitive therapy group includes Captain Log, which is a software to rehabilitate and enhance cognitive functions.
Main outcome variables
Balance؛, Cognitive Function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211228053555N1
Registration date: 2022-11-26, 1401/09/05
Registration timing: registered_while_recruiting

Last update: 2022-11-26, 1401/09/05
Update count: 0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Fatemeh Bahramian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0083
Email address
fbahramian69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of neurofeedback and cognitive rehabilitation on balance and cognitive function in the elderly
Public title
Effect of the neurofeedback and cognitive rehabilitation in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Those elderly who do not have cranial implants Those elderly who are able to walk independently without assistive devices Those elderly who have conscious consent to participate in research Those elderly who have no history of attending psychotherapy and neurofeedback sessions
Exclusion criteria:
old people with a definite diagnosis of neurological disorders, orthopedic disorders and cardiovascular and respiratory diseases old people with a visual or vestibular impairment, or those who taking medications which cause balance problems the elderly who had a score below 7 on the Brief cognitive test Personal reluctance to continue treatment
Age
From 65 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using sealed envelopes participants were randomly assigned to one of the three groups of study. The envelopes received numbers in advance (coded as 1, 2, and 3), and were opened sequentially, only after the participant’s name was written on the appropriate envelope. Random allocation sequences remained concealed from those enrolling participants into the study to minimize the effects of bias.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data for all subjects were obtained, by an investigator who was blinded to the treatment allocation
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave, Daneshjoo Blvd, Evin,Tehran, University of Social Welfare and Rehabilitation Science
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2021-12-27, 1400/10/06
Ethics committee reference number
IR.USWR.REC.1400.230

Health conditions studied

1

Description of health condition studied
The elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cognitive function
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Mini-Mental State Examination, Montreal Cognitive Assessment

2

Description
Balance
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Timed Up and Go test, the Berg Balance Scale (BBS)

Secondary outcomes

1

Description
Risk of falling
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Tinetti balance score

Intervention groups

1

Description
Intervention group1: Neurofeedback Neurofeedback therapy involve 16 sessions, with two sessions per week. Neurofeedback training will be conducted using neurofeedback devices with Procomp hardware (Ver.0.5,) and Biography software produced by TAT Technologies Company (Thought Technology Ltd, Canada The method of electrode placement in this protocol is that the active electrode (0.01 reference electrode) will be placed on (the cerebellum) and the grand electrode will be placed on the right ear. Then, in the intervention phase, animation will present to them. As the brain waves of the elderly move away from the intended target (ie, increasing the theta wave and decreasing the beta waves), the animation will stop. To replay the animation, the elderly have to change their brain waves in the direction of the intended target.
Category
Rehabilitation

2

Description
Intervention group2: Cognitive rehabilitation In this study, Captain Log cognitive rehabilitation treatment is performed in 16 sessions, 2 times a week for 60 minutes each time.The Captain Log program is one of the software programs designed by Train Brain in the United States to rehabilitate and enhance cognitive functions. This set has 2000 different programs and assignments and includes basic cognitive skills and superior skills. Also, this software set has three levels: simple, medium and difficult, which are determined according to the subject's condition.
Category
Rehabilitation

3

Description
Intervention group 3:Neurofeedback + Cognitive Neurofeedback therapy In total, this group has 4 treatment sessions per week, including two neurofeedback sessions and two cognitive therapy sessions.Neurofeedback therapy involve 16 sessions, with two sessions per week. Captain Log cognitive rehabilitation treatment is performed in 16 sessions, 2 times a week for 60 minutes each time..
Category
Rehabilitation

4

Description
Control group: This group does not receive treatment. Only every week their conditions are checked by phone.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Movafaghiyat clinic
Full name of responsible person
Seyed Abolfazl Mousavi
Street address
No. 7, Shariati Street, Between Mirdamad and Zafar, Falsafi Alley, baran Building
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 919 300 3160
Email
seyed.abalfazl@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
seyed abolfazl mousavi
Street address
kodakyar Ave, daneshjo Blvd, Evin, Tehran, university of social welfare and rehabilitation sciences
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 919 300 3160
Email
seyed.abalfazl@gmail.com
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
Movafaghiyat Clinic
Full name of responsible person
Seyed Abolfazl Mousavi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 7, Baran Building , Falsafy Alley, Between Mirdamad and Zafar Ave, Shariati St,Tehran Town.
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 919 300 3160
Email
seyed.abalfazl@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Movafaghiyat clinic
Full name of responsible person
Seyed Abolfazl Mousavi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 7, Baran Building , FalsaFy Alley, Between Mirdamad and Zafar Ave, Shariati St,Tehran Town.
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 919 300 3160
Email
seyed.abalfazl@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fatemeh Bahramian
Position
Student
Latest degree
Master
Other areas of specialty/work
Rehabilitation
Street address
Kodakyar Ave, Daneshjoo Blvd.,Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
0098 21 22180083-92
Email
fbahramian69@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic information and information on the main outcome
When the data will become available and for how long
Start of access period from 1401
To whom data/document is available
Researchers working in academic institutions and clinics
Under which criteria data/document could be used
Use for further research and review articles
From where data/document is obtainable
Seyed Abolfazl Mousavi
What processes are involved for a request to access data/document
Two weeks to review the request and check the purpose of receiving the data
Comments
Because the condition we are studying is not a disease, we leave the ICD-10 code and ICD-10 code description fields empty according to your guidline.
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