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The effect of motor control, neurological and cognitive exercises on psychological and kinetic variables of gait in patients with chronic nonspecific low back pain

Protocol summary

Study aim
The aim of the present study is the effect of motor, neurological and cognitive control exercises on the psychological and kinetic variables of walking in patients with non-specific chronic back pain.
Design
Clinical trial, with factorial groups, double-blind, randomized, on 100 patients, Random Number Generator software was used for randomization.
Settings and conduct
The present research is conducted in the sports rehabilitation laboratory of Boali Sina University, Hamadan. In this study, the subjects and the examiner were blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women between the ages of 30 and 60 years old, diagnosis and confirmation of non-specific chronic back pain by a specialist doctor Exclusion criteria: having a history of injury in the past year in the trunk and lower limbs, having a history of surgery in the back and lower limbs
Intervention groups
Individuals will be assigned to one of four groups: motor control exercises, motor control exercises combined with neurofeedback exercises, motor control exercises combined with cognitive exercises and a combined group (motor control exercises, neurofeedback exercises and cognitive exercises).
Main outcome variables
Measurement of pain, disability, fear of movement, muscle activity, vertical ground reaction force

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230430058033N1
Registration date: 2023-05-04, 1402/02/14
Registration timing: prospective

Last update: 2023-05-04, 1402/02/14
Update count: 0
Registration date
2023-05-04, 1402/02/14
Registrant information
Name
Azadeh Asgarpoor
Name of organization / entity
The University of Bo Ali Sina Hamedan
Country
Iran (Islamic Republic of)
Phone
+98 81 3830 3241
Email address
a.asgarpoor@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motor control, neurological and cognitive exercises on psychological and kinetic variables of gait in patients with chronic nonspecific low back pain
Public title
Investigating the effect of motor motor control, neurological and cognitive exercises on non-specific chronic back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between the ages of 30 and 60 Diagnosis and confirmation of non-specific chronic back pain by a specialist doctor Not participating in other sports activities Presence of at least two movement control disorders in Lomajoki movement control tests
Exclusion criteria:
Having a history of injury in the past year in the trunk and lower limbs A history of surgery in the back and lower limbs People with back pain of non-mechanical origin Participants if they have already experienced neurofeedback
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized based on Random Number Generator software.In addition to simple randomization, random sequence generation softwares are capable of generating random sequences by block method.Nowadays, due to its ease of use and saving time, this method has replaced other random sequence generation methods. And then, based on the concealment of the SNOSE method, the allocation is divided into one of four groups: motor control exercises, motor control exercises along with neurofeedback exercises.Movement control exercises along with cognitive exercises and combined group (motor control exercises, neurofeedback exercises and cognitive exercises) will be assigned.This method is one of the common methods of hiding random allocation.In this method, first, a random sequence is created by the Random Number Generator software, then, based on the sample size of the research, a number of envelopes with aluminum foil (for the lack of clarity of the contents of the envelopes), preparation and each of the random sequences created on A card is recorded and the cards are placed in the letter envelopes in order.In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order.At the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
During the initial test before the beginning of the training period and also the secondary test after the training, the researcher was not involved in the tests in any way and the tests were done by people who did not know about the plan.They were aware and acted completely anonymously according to the orders. The person who was in charge of analyzing the data did not know about the study and examined the data in general.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Buali Sina Hamadan University
Street address
Pajohesh Intersection, Mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Approval date
2022-09-14, 1401/06/23
Ethics committee reference number
IR.BASU.REC.1401.026

Health conditions studied

1

Description of health condition studied
Chronic non-specific back pain
ICD-10 code
S30.0XXS
ICD-10 code description
Contusion of lower back and pelvis, sequela

Primary outcomes

1

Description
Muscle activity
Timepoint
At the beginning of the study before the interventions and 60 days after the exercises
Method of measurement
EMG A device for measuring muscle activity

2

Description
vertical earth reaction force
Timepoint
At the beginning of the study before the interventions and 60 days after the exercises
Method of measurement
Foot pressure measuring device

3

Description
Brain Waves
Timepoint
At the beginning of the study before the interventions and 60 days after the exercises
Method of measurement
Neurofeedback device

4

Description
Cognitive function
Timepoint
At the beginning of the study before the interventions and 60 days after the exercises
Method of measurement
Fully listening to the patient in order to widely identify multidimensional stimuli that can change pain and disability (cognitive behaviors that trigger pain, movement, and lifestyle)

Secondary outcomes

1

Description
Visual measurement of pain
Timepoint
At the beginning of the study before the interventions and 60 days after the exercises
Method of measurement
Use the Visual Analogue Scale

2

Description
Disability
Timepoint
At the beginning of the study before the interventions and 60 days after the exercises
Method of measurement
Oswestry Disability Questionnaire

3

Description
Quality of Life
Timepoint
At the beginning of the study before the interventions and 60 days after the exercises
Method of measurement
Shernborn SF36 Questionnaire

Intervention groups

1

Description
Intervention group: Movement control exercises in eight weeks, three sessions a week and each session about 60 minutes (n=25). Movement control exercises will be performed in eight weeks, three sessions a week and each session will last about 60 minutes under the supervision of the researcher for all four exercise groups in the same way.This part will include about 10 minutes of general warm-up, about 40 minutes of movement control exercises and 10 minutes of cooling exercises in the form of stretching exercises.The movement control exercise program is based on the treatment program of Hodges et al. (2007).The primary goal of these exercises is to enable the patient to achieve control and coordination of the spine and pelvis using the principles of motor learning.
Category
Rehabilitation

2

Description
Intervention group: The group of motor control and neurofeedback exercises is a combination of two motor control and neurofeedback approaches.(n=25). Neurofeedback exercises will be conducted individually in the psychology laboratory of Bo Ali Sina University, Hamedan, 3 times a week for 30 minutes during eight weeks. The selected protocol for neurofeedback exercises will be in accordance with previous studies in the form of increasing the sensorimotor rhythm and decreasing beta and theta in the CZ region.Brain waves are processed by an amplifier and a computer device and provide appropriate feedback. The feedback process is like a person playing a computer game on his monitor.Unlike common games, a person does not use his hand to control the game, but does it through his brain waves
Category
Rehabilitation

3

Description
Intervention group: The group of motor and cognitive control exercises is a combination of two motor and cognitive control approaches (n= 25). Cognitive exercises will be done individually for eight weeks, 3 sessions a week for 30 minutes in the psychology laboratory of Bo Ali Sina University, Hamedan. It will include listening to the patient's full story about their pain. This careful examination is essential in order to broadly identify modifiable multidimensional drivers of pain and disability (pain-triggering cognitive behaviors, movement, and lifestyle) for each participant.Each patient receives an individual targeted intervention aimed at changing individual cognitive, motor and lifestyle behaviors.
Category
Rehabilitation

4

Description
Intervention group: the combined group of motor control and neurocognitive exercises (n=25). In this way, movement control exercises will be performed on even days and neurological and cognitive exercises will be performed on odd days.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Baath Hospital
Full name of responsible person
Ali Yalfani
Street address
Pajohesh Intersection, Mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3838 1601
Email
Ali_yalfani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Bu Ali Sina
Full name of responsible person
Ali Yalfani
Street address
Pajohesh Intersection, mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3838 1601
Email
Ali_yalfani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Bu Ali Sina
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

2

Sponsor
Name of organization / entity
The University of Bu Ali Sina
Full name of responsible person
Arash Ghorbani
Street address
Pajohesh Intersection, mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3838 1601
Email
a.ghorbani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Bu Ali Sina
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
The University of Bu Ali Sina
Full name of responsible person
Azadeh Asgarpoor
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercise and Sports Injures
Street address
No. 4, Imam Reza Blvar, Moalem Square
City
Shahre Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
888-1111-311
Phone
+98 38 3224 1992
Email
azadehasgarpoor@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Bu Ali Sina
Full name of responsible person
Azadeh Asgarpoor
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercise and Sports Injures
Street address
No 4, Imam Reza Blvar, Moalem Square
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
888-1111-311
Phone
+98 38 3224 1992
Email
azadehasgarpoor@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Bu Ali Sina
Full name of responsible person
Azadeh Asgarpoor
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercise and Sports Injures
Street address
No 4, Imam Reza Blvar, Moalem Square
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
888-1111-311
Phone
+98 38 3224 1992
Email
azadehasgarpoor@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
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
All data and documentation can be shared, but with the unidentifiable of people and private information for subjects
When the data will become available and for how long
Starting Data access 1 year after printing results
To whom data/document is available
Researchers who conduct research in this direction are allowed to take action to receive documents
Under which criteria data/document could be used
Only the type of analysis that can be done in the research can be redefined.It can also use the training protocol. Obligation not to misuse research data
From where data/document is obtainable
azadehasgarpoor@gmail.com
What processes are involved for a request to access data/document
When the applicant submits a documents for her/his work area in relation to the subject matter of the thesis and if the request is reasonable and the commitment not to misuse the data of this research, the data will be sent to him within 1 week of work
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