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临床试验/CTRI/2025/09/095462
CTRI/2025/09/095462尚未招募不适用

Combined Effect Of Abdominal Functional Electrical Stimulation And Inspiratory Muscle Training On Respiratory Function In Individuals With Spinal Cord Injury

Indian Spinal Injuries Center Institute Of Rehabilitation Sciences1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年10月10日最近更新:

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

发起方
Indian Spinal Injuries Center Institute Of Rehabilitation Sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Manpreet Kaur

Indian Spinal Injuries Center And Institute Of Rehabilitation Sciences

研究点 (1)

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