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临床试验/CTRI/2025/01/079329
CTRI/2025/01/079329招募中不适用

Development of a respiratory function assessment and rehabilitation device for participants with spinal cord injury.

Indian Spinal Injuries Centre1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Maximal Inspiratory pressure

研究概览

简要总结

People with spinal cord injury face respiratory compromise due to loss of innervation to the primary muscles of respiration. The weakness in respiratory muscles predisposes to a deterioration in pulmonary function in the spinal cord injury population due to weakened cough effort secondary to weakness of respiratory muscles and secretion stagnation. In the acute phase of injury, the flaccid muscles of the chest wall exhibit paradoxical in drawing with pressure changes in the thorax. This increases the risk of acute respiratory failure, atelectasis, pneumonia and other pulmonary infections. The degree of impairment depends on the neurological level of injury, the completeness of the injury and the time since the injury. Inspiratory muscle training has emerged as a promising tool in the respiratory rehabilitation of persons with SCI. A review article advocated the early incorporation of inspiratory muscle training (IMT) show significant improvements in the respiratory muscle strength and to an extent may be helpful for preventing respiratory complications. The literature mostly included hospital-based intervention for IMT. Literature has highlighted the fact that respiratory complications are a major contributor to re-admissions in chronic SCI. The assessment of respiratory muscle strength post injury is a major predictor of respiratory complications.

IMT being such a crucial part of the rehabilitation become a monotonous training without frequent reassessments. There is a need for a way of providing IMT training to individuals, including regular reassessment and alteration in level of training accordingly. A pilot study did examine the feasibility of a game-based approach for breathing exercises. The preliminary results have been promising with significant improvement in pulmonary functions. The lacunae of reassessment of the respiratory muscle strength in the app-based training persisted. Thus, the current study aims to provide a technology based IMT training and assessment for people with spinal cord injury.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age between 18 – 60 years Traumatic complete lesion ( AIS A or B) Individuals between C4-T6 level of injury Non-Mechanically ventilated patients.

排除标准

  • Any participant with diagnosed neurological disease other than spinal cord injury and pulmonary disease Patient on tracheostomy.

结局指标

主要结局

Maximal Inspiratory pressure

时间窗: 0 week and 6 week

次要结局

  • MAximal expiratory pressure(0 week and 6 week)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Shambhovi Mitra

Indian Spinal injuries centre

研究点 (1)

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