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临床试验/CTRI/2023/06/054586
CTRI/2023/06/054586尚未招募不适用

Effect of Inspiratory Muscle Training on Seated Balance and Respiratory Function in people with Spinal Cord Injury

Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年7月31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
44
试验地点
1
主要终点
Seated Balance using Function in Sitting Test-Spinal Cord Injury (FIST-SCI)

研究概览

简要总结

This study is a randomised, double-blind, parallel group, single-centre trial to determine the effect of inspiratory muscle training on the seated balance and respiratory function in individuals with Spinal cord injury. Individuals will be randomly assigned to intervention or comparator groups. Training to intervention group will be given via flow-resistive IMT (PrO2Fit) while comparator group will recieve training via incentive spirometer for 4 days a week for a period of 6 weeks. Assessment of seated balance will be done using FIST-SCI scale and respiratory function will be assessed by MIP, SMIP and total power. Assessment will be done at the time of allocation and at the end of fourth and sixth week of training.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • Acute traumatic spinal cord injury (less than 1 year since injury) Spinal cord injury of level C4 to T6 ASIA grade A, B or C Patients who are not receiving mechanical ventilation.

排除标准

  • Tracheostomy Subjects with diagnosed pulmonary conditions like asthma, COPD, etc.
  • Subjects with diagnosed head injury or neurological diseases other than spinal cord injury Visual or auditory impairment which may interfere with participation.

结局指标

主要结局

Seated Balance using Function in Sitting Test-Spinal Cord Injury (FIST-SCI)

时间窗: T0- at the time of allocation | T1- after 4 weeks of training | T2- after 6 weeks of training

次要结局

  • Respiratory function using Maximal Inspiratory Pressure (MIP), Sustained Maximal Inspiratory Pressure (SMIP) & Total Power (TP)(T0- at the time of allocation)

研究者

发起方
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
申办方类型
Research institution and hospital

研究点 (1)

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