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临床试验/CTRI/2024/10/075261
CTRI/2024/10/075261招募中不适用

Effect of respiratory muscle proprioceptive neuromuscular facilitation on respiratory muscle strength in spinal cord injury individuals

NA1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
NA
入组人数
20
试验地点
1
主要终点
Maximum inspiratory pressure

研究概览

简要总结

Spinal cord injury (SCI) can lead to significant respiratory complications due to impaired function of respiratory muscles. Proprioceptive neuromuscular facilitation (PNF) is a rehabilitation technique used to strengthen these muscles, showing efficacy in various populations, including those with COPD and weaning failure. While inspiratory muscle training (IMT) has proven beneficial in patients with tetraplegia, the combination of respiratory PNF and IMT on respiratory strength in SCI patients remains unexplored.

Study procedure

After baseline assessment and allocation of 20 quadriplegic subjects (C5-C8), participants will be divided into two groups: the experimental group, which will receive inspiratory muscle training (IMT) combined with respiratory muscle proprioceptive neuromuscular facilitation (PNF) and conventional physiotherapy, and the control group, which will receive sham training (PNF + IMT) along with conventional physiotherapy.In the experimental group: IMT: Participants will perform 3-5 sets of 12 breaths, followed by 2 minutes of quiet breathing. The intensity will start at 30% of their maximum inspiratory pressure (MIP/PI max) and will increase by 10% weekly, or by 5% if the higher increase is not tolerated. The training will take place 4 days per week for 4 weeks. PNF: Participants will perform 10-12 repetitions per set, for 3 sets per session. Each set will be followed by a 30-60 second rest period. This will also be conducted 4 days per week for 4 weeks.In the control group:Sham training (PNF + IMT): The same frequency, intensity, and time frame will be followed as the experimental group, but using sham techniques instead.The total session time will be approximately 30-40 minutes, and the primary outcome, respiratory muscle strength, will be assessed using MIP and MEP measurements.

Assessment: Primary Outcome: Respiratory muscle strength (measured by MIP and MEP) using a respiratory pressure manometer.

Statistical Analysis Plan:

Descriptive statistics will summarize data. Depending on data distribution, independent t-tests or Mann-Whitney U tests will compare groups, and paired t-tests or Wilcoxon signed-rank tests will evaluate pre- and post-intervention differences. Analysis will be performed using SPSS 21, with significance set at 5%.

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

  • 1.Tetraplegics (level of injury C5- C8) 2.ASIA Impairment scale-A and B 3.Medically stable as deemed by treating physician.

排除标准

  • 1.History of lung disease (asthma, COPD, restrictive disease of lungs) 2.Recent Thoracic or abdominal surgery 3.Recent ribs fracture 4.Chest wall deformity.

结局指标

主要结局

Maximum inspiratory pressure

时间窗: 0 week(baseline/pre test) and 4th week (post test)

次要结局

  • Maximum expiratory pressure

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Mansi Negi

Indian spinal injuries center-institute of rehabilitation sciences

研究点 (1)

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