Effectiveness of Resistive Respiratory Training using Breather Device Versus Inspiratory Muscle Training in Enhancing the Trunk Stability among Spinal cord Injury Survivors: A Randomized Control Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. Thickness of Diaphragm and Rectus abdominis muscle.
研究概览
简要总结
The study aims to investigate the impact of expiratory muscle training and trunk stabilization on sitting balance and quality of life in individuals with spinal cord injuries, specifically those with neurological levels of T1 to T7. The research will recruit 68 participants set at 10% attrition with each group having 34 participants. The research will commence after obtaining ethical clearance and registration with the Clinical Trials Registry of India (CTRI). The preliminary phase involves a pilot study with spinal cord injury survivors aged 18 to 50, having injuries from T1 to T7, with a minimum post-surgery recovery period of 15 days.
To assess initial sitting balance, the Trunk Control Test (TCT) will be conducted, and participants scoring ≤ 1 on the TCT will be included. Respiratory muscle strength, sitting balance, and quality of life will be evaluated using ultrasound sonography, sitting balance measurement (SBM), and the Spinal Cord Independence Measure (SCIM), respectively, as baseline assessments.
Two intervention groups, Group A and Group B, will undergo respiratory muscle training using the Respiratory Muscle Trainer (RMT) Breather and Threshold inspiratory muscle training, respectively. The protocol includes 20 minutes of RMT usage and trunk stabilization exercises, twice daily, six times a week for three weeks.
After the intervention, respiratory muscle strength, sitting balance, and quality of life will be reassessed. Upper-body sway will be measured using a modified Lord sway meter, and the study will focus on three components: maximal lateral displacement, maximal anterior-posterior displacement, and the total length of the sway path.
Preliminary results from the acute, chronic, and high T1-T7 level of injury groups indicate variations in sway path lengths and displacements. Quality of life improvements will be specifically evaluated in terms of enhanced trunk stability and sitting balance.
In summary, this study aims to provide valuable insights into the effects of expiratory muscle training and trunk stabilization on sitting balance and quality of life in individuals with spinal cord injuries, focusing on those with neurological levels of T1 to T7.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Participants must be between the ages of 18 and 50 and have traumatic paraplegia resulting from a spinal cord injury at the neurological level of T1-T
- •2 ASIA scale A and B 3 Spinal cord injury survivors with a sitting balance score of ≤ 1 on the trunk control test.
- •(TCT) 4 Participants must be at least 15 days post-surgery and medically stable.
排除标准
- •Participants will be excluded from the study if; 1 Traumatic Brain Injury.
- •2 The individuals are not able to follow the instructions.
- •3 Traumatic pneumothorax that has not fully healed.
- •5 Unstable asthma with an abnormally low perception of dyspnoea.
- •6 Major fractures in the lower limb like the Pelvis and long bones.
- •7 Neuromuscular disorders.
- •8 Preexisting neurological disease.
结局指标
主要结局
1. Thickness of Diaphragm and Rectus abdominis muscle.
时间窗: At the baseline of the study and upon completion of the 3-week evaluation.
2. Sitting Balance: Sitting balance Measure and Lord Sway meter.
时间窗: At the baseline of the study and upon completion of the 3-week evaluation.
次要结局
- Quality of life: Spinal cord independence Measure.(Upon completion of 3 weeks of intervention.)
研究者
Rinku Roshan
Father Muller Medical College