Investigating the effect of electromyographic respiratory biofeedback by applying it on external and internal intercostal muscles and diaphragm, on pulmonary function, anxiety level and severity of hyperventilation syndrome in male patients with incomplete cervical spinal cord injury
Determining the effect of electromyographic respiratory biofeedback by applying it on external and internal intercostal muscles and diaphragm, on pulmonary function, anxiety level and severity of hyperventilation syndrome in male patients with incomplete cervical Spinal Cord Injury (SCI)
Design
This study is a clinical trial type with a control group, with parallel groups, without blinding and randomized and it is conducted on 40 patients. The block randomization method is also used for randomization
Settings and conduct
Men with cervical spinal cord injury who are residents of Kehrizak Charity Hospital in Tehran will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using the random block method.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Men with quadriplegia due to incomplete cervical SCI (from the level of the third cervical nerve down) between the ages of 25 and 40 years who have criteria B and C of the ASIA scale and have hyperventilation syndrome and high levels of anxiety.
Exclusion Criteria:
Less than two months have passed since the cervical SCI
Intervention groups
This study includes two groups. The control group receives 15 sessions of common respiratory physiotherapy treatment (3 sessions per week) including working with light weights and stationary hand and leg bicycles, and the intervention group, in addition to common respiratory physiotherapy treatment, They will also receive 15 sessions of respiratory biofeedback therapy. The duration of common respiratory physiotherapy in each session is 30 minutes and the duration of biofeedback is 25 minutes.
Main outcome variables
respiratory efficiency; severity of hyperventilation syndrome; Anxiety level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230302057593N1
Registration date:2023-07-22, 1402/04/31
Registration timing:registered_while_recruiting
Last update:2023-07-22, 1402/04/31
Update count:1
Registration date
2023-07-22, 1402/04/31
Registrant information
Name
Soroush Hasnakipor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6534 0815
Email address
hasnakisoroush@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-11, 1402/04/20
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of electromyographic respiratory biofeedback by applying it on external and internal intercostal muscles and diaphragm, on pulmonary function, anxiety level and severity of hyperventilation syndrome in male patients with incomplete cervical spinal cord injury
Public title
Evaluation of the effectiveness of biofeedback in the treatment of the respiratory and psychological systems of patients with cervical spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men with quadriplegia due to incomplete cervical spinal cord injury (from the level of the third cervical nerve down) between the ages of 25 and 40 years who have criteria B and C of the ASIA scale.
Men with cervical spinal cord injury (criteria B and C of the ASIA scale) (from the level of the third cervical nerve down) whose score is 23 or higher in the Nijmegen questionnaire
Men with cervical spinal cord injury (criteria B and C of the ASIA scale) (from the level of the third cervical nerve down) whose scores in the Zang questionnaire are between 45 and 75
Consciousness of the tested person based on clinical observations and the patient's own statements
Absence of hemoptysis of unknown origin obtained through the patient's medical record
The absence of untreated pneumothorax, which is obtained by examining the patient's medical record
Absence of tracheostomy in the body of a person with cervical spinal cord injury
The test subject does not suffer from acute anxiety disorders related to drugs
The test subject's non-use of any psychoactive drugs
Absence of an unstable cardiovascular condition, which is obtained by examining the medical record of the subject
Exclusion criteria:
Less than two months have passed since the Cervical Spinal Cord injury
Using mechanical ventilation for the subject
Age
From 25 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Block method will be used for randomization in this study. In this method, several blocks are assigned and the the randomization unit is also individual. Randomization is done through the software available at www.sealedenvelope.com. The randomization sequence will be done in such a way that each person will have an equal chance to be in the control or intervention group. Each block will consist of 4 patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Rehabilitation Sciences and Social Health
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.USWR.REC.1401.254
Health conditions studied
1
Description of health condition studied
Cervical Spinal Cord Injury
ICD-10 code
S14.1
ICD-10 code description
Other and unspecified injuries of cervical spinal cord
Primary outcomes
1
Description
Forced Expiratory Volume in the first second(FEV1) Pulmonary Index which obtained by Spirometry test.
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Spirometer
2
Description
Forced Vital Capacity(FVC) Pulmonary Index which obtained by Spirometry test.
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Spirometer
3
Description
Pulmonary index FEV1/FVC which obtained by spirometry test.
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Spirometer
4
Description
Forced expiratory flow between 25% and 75% of vital capacity Pulmonary Index which obtained by spirometry test.
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Spirometer
5
Description
Peak Expiratory Flow (PEF) Pulmonary Index which obtained by Spirometry test.
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Spirometer
6
Description
Maximum Voluntary Ventilation (MVV) Pulmonary Index which obtained by Spirometry test.
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Spirometer
7
Description
Tidal Volume (TV) Pulmonary Index which obtained by Spirometry test.
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Spirometer
8
Description
Anxiety lavel in the Zung questionnaire
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Zung questionnaire
9
Description
Severity of hyperventilation syndrome in Nijmegen questionnaire
Timepoint
Before the start of the first treatment session, immediately after the end of the last treatment session and one month after the end of the last treatment session
Method of measurement
Nijmegen questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to common respiratory physiotherapy, they receive electromyographic respiratory biofeedback. This intervention is performed by placing surface electrodes on the patient's respiratory muscles. Biofeedback treatment is performed in the form of 15 sessions of 25 minutes, three times a week.
Category
Rehabilitation
2
Description
Control group: receive common respiratory physiotherapy. Common respiratory physiotherapy is defined as doing aerobic exercises, working with light weights and working with hand and foot stationary bikes. The control group received common respiratory physiotherapy in the form of 15 sessions of 30 minutes and 3 times a week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
kahrizak charity foundation
Full name of responsible person
Dr. Hassan Nahvi Nejad
Street address
Hafte Tir Square , Northern Mofateh Street , Shahid Molayari Street , Apartment No. 110 ,Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1819117536
Phone
+98 21 8831 0688
Email
pr@kahrizak.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
seyed Ali Hosseini
Street address
kodakyar Ave., daneshjo Blvd.,Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
webmaster@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Rehabilitation Sciences and Social Health
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
Tehran University of Rehabilitation Sciences and Social Health
Full name of responsible person
Soroush Hasnaki Pour
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Unit. 11, Block. 4, Agricultural Residential Complex., Shohadaye Gomnam Square., Phase. 4 of New Andisheh City
City
Shahriar
Province
Tehran
Postal code
3354943007
Phone
+98 21 6534 0815
Email
hasnakisoroush@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Rehabilitation Sciences and Social Health
Full name of responsible person
Soroush Hasnaki Pour
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Unit. 11, Block. 4, Agricultural Residential Complex., Shohadaye Gomnam Square., Phase. 4 of New Andisheh City
City
Shahriar
Province
Tehran
Postal code
3354943007
Phone
+98 21 6534 0815
Email
hasnakisoroush@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Rehabilitation Sciences and Social Health
Full name of responsible person
Soroush Hasnaki Pour
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Unit. 11, Block. 4, Agricultural Residential Complex., Shohadaye Gomnam Square., Phase. 4 of New Andisheh City
City
Shahriar
Province
Tehran
Postal code
3354943007
Phone
+98 21 6534 0815
Email
hasnakisoroush@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
In this study and after obtaining informed consent from the subjects, all the information obtained in all stages of the study can be published without mentioning the subject's name
When the data will become available and for how long
Access to the data of this study is possible six months after its publication in a journal
To whom data/document is available
Access to the data of this research is possible only for researchers affiliated with educational centers and participating subjects
Under which criteria data/document could be used
Using the data of this research and analyzing them is possible only with the permission of the authors of this research and for scientific and educational purposes
From where data/document is obtainable
To receive the data of this research and communicate with its authors, the only way to communicate is to send an email to hasnakisoroush@gmail.com
What processes are involved for a request to access data/document
To access the data of this research, the applicant must first email the documents of his scientific and educational work to the authors of this research along with a full description of the purpose of accessing the data and also the type of affiliation to the desired educational center. After reviewing the documents of the applicant, the authors will reply to the email as soon as possible and provide them with the data that can be shared