Combined Effect Of Abdominal Functional Electrical Stimulation And Inspiratory Muscle Training On Respiratory Function In Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Peak Expiratory Flow
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •AIS A ,B And C. Level Of Injury.
排除标准
- •Any Clinically Diagnosed Neurological Disorder Other Than SCI Any Other Pre-diagnosed Respiratory Conditions Like COPD, Asthma Etc.
结局指标
主要结局
Peak Expiratory Flow
时间窗: T0 - at the time of allocation. | T1- after completion of 6 sessions. | T2- after completion of all 12 sessions.
次要结局
- 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)
研究者
Manpreet Kaur
Indian Spinal Injuries Center And Institute Of Rehabilitation Sciences
