Combined Effect Of Abdominal Functional Electrical Stimulation And Inspiratory Muscle Training On Respiratory Function In Individuals With Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Indian Spinal Injuries Center Institute Of Rehabilitation Sciences
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Peak Expiratory Flow
Overview
Brief Summary
This study is randomised, double blinded, parallel group, single centre trial, examines the combined effect of Abdominal Functional Electrical Stimulation (FES) and Inspiratory Muscle Training (IMT) on respiratory function in individuals with spinal cord injury (SCI). Individuals will be Randomly assigned to intervention and comparator groups. Training to interventional group will be given via flow resistive IMT (Pro2Fit) along with Abdominal Functional Electrical Stimulation While Comparator group will receive sham training of both interventions (IMT And Abdominal FES) for 3 to 4 days a week for a period of 3 to 4 weeks (total 12 sessions). Assessment of respiratory function will be done - Maximal inspiratory pressure (MIP), Sustained Maximal inspiratory pressure (SMIP), Total power, Fatigue index test (FIT). Assessment of Feasibility parameters - Safety, Satisfaction and Adherence. Assessment of these parameters at time of allocation, after completion of 6 sessions the after completion of total 12 sessions will be done.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •AIS A ,B And C. Level Of Injury.
Exclusion Criteria
- •Any Clinically Diagnosed Neurological Disorder Other Than SCI Any Other Pre-diagnosed Respiratory Conditions Like COPD, Asthma Etc.
Outcomes
Primary Outcomes
Peak Expiratory Flow
Time Frame: T0 - at the time of allocation. | T1- after completion of 6 sessions. | T2- after completion of all 12 sessions.
Secondary Outcomes
- Respiratory function using Maximal Inspiratory Pressure (MIP), Sustained Maximal Inspiratory Pressure (SMIP), Total power And Fatigue Index Test (FIT)(T0 - at the time of allocation.)
- Feasibility Outcomes - Safety, Satisfaction And Adherence.(at the end of each session)
Investigators
Manpreet Kaur
Indian Spinal Injuries Center And Institute Of Rehabilitation Sciences