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临床试验/NCT07821255
NCT07821255尚未招募不适用

Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke: A Randomized Controlled Trial

fatma shehata0 个研究点目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Trunk Impairment Scale

研究概览

简要总结

This randomized controlled trial will investigate whether adding diaphragmatic breathing training to conventional physiotherapy improves trunk control and postural stability in individuals with chronic stroke compared with conventional physiotherapy alone. Forty participants with chronic unilateral stroke will be randomly allocated in a 1:1 ratio to either an experimental group receiving diaphragmatic breathing training plus conventional physiotherapy or a control group receiving conventional physiotherapy alone. The intervention will be provided three times per week for six weeks.

详细描述

The study will use a prospective, two-arm, parallel-group randomized controlled design. Forty individuals with chronic unilateral stroke will be recruited and randomly allocated to either an experimental group or a control group in a 1:1 ratio.

The experimental group will receive standard diaphragmatic breathing training in addition to conventional physiotherapy. The control group will receive the same conventional physiotherapy program without diaphragmatic breathing training.

Both groups will receive three treatment sessions per week for six weeks, for a total of 18 sessions.

Trunk control and postural stability will be assessed at baseline and after completion of the six-week intervention. Trunk control will be assessed using the Trunk Impairment Scale, while postural stability will be assessed using the Biodex Balance System. Functional mobility will be assessed using the Timed Up and Go test.

Primary C

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 40-65 years.
  • Clinically diagnosed unilateral stroke.
  • Chronic stroke stage of at least 6 months.
  • Able to sit independently without physical assistance.
  • Able to walk 10 meters with or without an assistive device.
  • Mini-Mental State Examination (MMSE) score ≥
  • Modified Ashworth Scale (MAS) score ≤2 in the affected upper and lower limb muscles.
  • Medically stable.
  • Able to understand and follow simple instructions.
  • Willing to participate and provide written informed consent.

排除标准

  • Other neurological disorders.
  • Bilateral neurological deficits or multiple deficits substantially interfering with trunk control, balance, or gait.
  • Severe cardiopulmonary disease limiting participation in exercise.
  • Severe musculoskeletal disorders affecting the trunk or lower limbs.
  • Severe cognitive impairment.
  • Severe aphasia preventing understanding of instructions.
  • Significant visual or vestibular impairment affecting balance assessment.
  • Uncontrolled medical conditions.
  • Current participation in another structured rehabilitation program.

研究组 & 干预措施

Diaphragmatic Breathing Training and Conventional Physiotherapy

Experimental

Participants will receive conventional physiotherapy combined with standard diaphragmatic breathing training. Diaphragmatic breathing training will involve slow nasal inspiration emphasizing abdominal/lower rib cage expansion, followed by slow controlled oral expiration while minimizing upper chest and shoulder movement. Training will be provided for approximately 10-15 minutes per session, three sessions per week for six weeks.

干预措施: Diaphragmatic Breathing Training and Conventional Physiotherapy (Behavioral)

Conventional Physiotherapy

Active Comparator

Participants will receive the same standardized conventional physiotherapy program as the experimental group without diaphragmatic breathing training. Treatment will be provided three sessions per week for six weeks.

干预措施: Diaphragmatic Breathing Training and Conventional Physiotherapy (Behavioral)

结局指标

主要结局

Trunk Impairment Scale

时间窗: Baseline (Week 0) and post-intervention (Week 6)

Trunk control will be assessed using the original 17-item Trunk Impairment Scale, which evaluates static sitting balance, dynamic sitting balance, and coordination. Total scores range from 0 to 23, with higher scores indicating better trunk control.

Trunk Impairment Scale (TIS)

时间窗: Baseline (Week 0) and post-intervention (Week 6)

Trunk control will be assessed using the original 17-item Trunk Impairment Scale, which evaluates static sitting balance, dynamic sitting balance, and coordination. Total scores range from 0 to 23, with higher scores indicating better trunk control.

Biodex Postural Stability

时间窗: Baseline (Week 0) and post-intervention (Week 6)

Postural stability will be assessed using the Biodex Balance System. The selected postural stability index will be recorded under standardized testing conditions, with the same test configuration used at baseline and post-intervention.

次要结局

  • Timed Up and Go (TUG)(Baseline (Week 0) and post-intervention (Week 6))

研究者

发起方
fatma shehata
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

fatma shehata

lecturer

Suez University

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