Protocol summary
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Study aim
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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)
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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respiratory efficiency; severity of hyperventilation syndrome; Anxiety level
General information
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Reason for update
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The information about the start of sampling and the end of sampling was modified based on the fact that it was done. Previously, the information was not recorded correctly.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230302057593N1
Registration date:
2023-07-22, 1402/04/31
Registration timing:
prospective
Last update:
2024-07-29, 1403/05/08
Update count:
1
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Registration date
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2023-07-22, 1402/04/31
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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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2023-08-11, 1402/05/20
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Expected recruitment end date
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2024-03-20, 1403/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Evaluation of the effectiveness of biofeedback in the treatment of the respiratory and psychological systems of patients with cervical spinal cord injury
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 40 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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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2023-03-15, 1401/12/24
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Ethics committee reference number
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IR.USWR.REC.1401.254
Health conditions studied
1
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Description of health condition studied
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Cervical Spinal Cord Injury
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ICD-10 code
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S14.1
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ICD-10 code description
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Other and unspecified injuries of cervical spinal cord
Primary outcomes
1
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Description
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Forced Expiratory Volume in the first second(FEV1) Pulmonary Index which obtained by Spirometry test.
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Timepoint
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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
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Method of measurement
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Spirometer
2
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Description
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Forced Vital Capacity(FVC) Pulmonary Index which obtained by Spirometry test.
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Timepoint
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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
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Method of measurement
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Spirometer
3
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Description
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Pulmonary index FEV1/FVC which obtained by spirometry test.
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Timepoint
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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
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Method of measurement
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Spirometer
4
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Description
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Forced expiratory flow between 25% and 75% of vital capacity Pulmonary Index which obtained by spirometry test.
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Timepoint
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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
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Method of measurement
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Spirometer
5
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Description
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Peak Expiratory Flow (PEF) Pulmonary Index which obtained by Spirometry test.
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Timepoint
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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
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Method of measurement
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Spirometer
6
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Description
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Maximum Voluntary Ventilation (MVV) Pulmonary Index which obtained by Spirometry test.
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Timepoint
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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
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Method of measurement
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Spirometer
7
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Description
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Tidal Volume (TV) Pulmonary Index which obtained by Spirometry test.
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Timepoint
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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
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Method of measurement
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Spirometer
8
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Description
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Anxiety lavel in the Zung questionnaire
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Timepoint
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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
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Method of measurement
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Zung questionnaire
9
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Description
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Severity of hyperventilation syndrome in Nijmegen questionnaire
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Timepoint
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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
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Method of measurement
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Nijmegen questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
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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No
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Title of funding source
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Tehran University of Rehabilitation Sciences and Social Health
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Proportion provided by this source
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100
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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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Yes - There is a plan to make this available
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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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Undecided - It is not yet known if there will be 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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Yes - There is a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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
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When the data will become available and for how long
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Access to the data of this study is possible six months after its publication in a journal
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To whom data/document is available
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Access to the data of this research is possible only for researchers affiliated with educational centers and participating subjects
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Under which criteria data/document could be used
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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
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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
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Comments
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