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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230302057593N1
Enrollment
40
Registered
2023-07-22
Start date
2023-08-11
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spinal Cord Injury. Other and unspecified injuries of cervical spinal cord

Interventions

Intervention 1: Intervention group: In addition to common respiratory physiotherapy, they receive electromyographic respiratory biofeedback. This intervention is performed by placing surface electrode

Sponsors

Tehran University of Rehabilitation Sciences and Social Health
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
25 Years to 40 Years

Inclusion 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

Exclusion criteria: Less than two months have passed since the Cervical Spinal Cord injury Using mechanical ventilation for the subject

Design outcomes

Primary

MeasureTime frame
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.;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.;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.;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.;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.;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.;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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoroush Hasnaki Pour

Tehran University of Rehabilitation Sciences and Social Health

hasnakisoroush@gmail.com+98 21 6534 0815

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026