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临床试验/CTRI/2025/08/093194
CTRI/2025/08/093194尚未招募不适用

To evaluate the effect of wheelchair skills training program in enhancing pulmonary function and quality of life in persons with spinal cord injury

Pt B. D. Sharma PGIMS, Rohtak, Haryana, India, 1240011 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月26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
40
试验地点
1
主要终点
Pulmonary Function Test(PFT)

研究概览

简要总结

**Background:**Spinal cord injury (SCI) often leads to respiratory muscle weakness, reduced lung volumes, and impaired functional abilities. Pulmonary complications are a leading cause of morbidity and mortality in this population. Wheelchair skills training programs (WSTP) and cardiopulmonary exercise interventions may help improve pulmonary function, dyspnoea levels, mobility, and quality of life.

**Objectives:**To evaluate and compare the effects of WSTP combined with cardiopulmonary exercise intervention versus conventional physiotherapy with wheelchair manoeuvring on pulmonary function, dyspnoea, functional abilities, and quality of life in individuals with thoracic SCI.

**Methods:**A total of 40 participants diagnosed with thoracic SCI (ASIA B/C) will be randomly allocated into two groups:

Group A (n=20): (Experimental group)  Conventional cardiopulmonary physiotherapy + WSTP.

Group B (n=20): (Control group) Conventional chest physiotherapy + wheelchair manoeuvring.

Outcome measures: Pulmonary Function Test (PFT), 12 Minute Wheelchair Aerobic Test (12MWAT), Modified Borg Scale (MBS), Spinal Cord Independence Measure-IV (SCIM-IV), and WHOQOL-BREF Questionnaire. Data will be analysed using SPSS.

**Result:**Results will indicate the effects of the two interventions on pulmonary function, dyspnoea levels, functional abilities, and quality of life in individuals with thoracic SCI.

Conclusion:The study will provide evidence on the role of WSTP combined with cardiopulmonary exercise in improving respiratory and functional outcomes in persons with thoracic SCI, potentially guiding rehabilitation practices.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

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.Minimum post-injury duration of 6 months.
  • 2.Ability to sit independently.
  • 3.Diagnosed as a thoracic spinal cord injury (T-SCI) and categorized B/C according to ASIA classification system.

排除标准

  • 1.Presence of pressure sores.
  • 2.Neurological condition other than SCI such as stroke, traumatic brain injury and degenerative brain disease.
  • 3.Medical history affecting pulmonary function such as COPD, bronchial asthma.
  • 4.Body mass index 30 or greater.

结局指标

主要结局

Pulmonary Function Test(PFT)

时间窗: Baseline, after 4 weeks, after 2 months

12 minute wheelchair aerobic test (12 MWAT)

时间窗: Baseline, after 4 weeks, after 2 months

Modified Borg Scale (MBS)

时间窗: Baseline, after 4 weeks, after 2 months

WHOQOL-BREFQuestionnaire

时间窗: Baseline, after 4 weeks, after 2 months

次要结局

  • Spinal cord independence measure-IV(SCIM-IV)(Baseline, after 4 weeks, after 2 months)

研究者

发起方
Pt B. D. Sharma PGIMS, Rohtak, Haryana, India, 124001
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aarti Sharma

College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

研究点 (1)

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