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临床试验/CTRI/2025/11/097193
CTRI/2025/11/097193尚未招募2/3 期

Impact of Posture Correction on respiratory functions in adults with forward head posture: A randomized controlled trial.

Indian Spinal Injuries CentreInstitute of Rehabilitation Sciences1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
Peak Expiratory Flow(PEF)

研究概览

简要总结

1. Title : IMPACT OF POSTURE CORRECTION ON RESPIRATORY FUNCTIONS IN ADULTS WITH FORWARD HEAD POSTURE: A RANDOMIZED  CONTROL STUDY

2. Background/Introduction/Review of Literature: Young adults commonly develop postural deviations such as thoracic hypokyphosis and forward head posture (FHP) due to prolonged screen use. FHP involves upper cervical extension and lower cervical flexion, resulting in altered cervical muscle balance, anterior muscle tightness, and impaired respiratory mechanics including reduced diaphragmatic contraction and thoracoabdominal mobility.

Faulty posture and lifestyle changes contribute to respiratory dysfunction. Studies report that 83% of individuals with posture-related neck pain exhibit altered breathing patterns, indicating a link between cervical posture and respiration.

However, evidence on the effect of postural correction on respiratory function in individuals with FHP remains limited, highlighting a gap in the literature.

  3. Objectives and Hypothesis

·        Primary Objective:

How does postural correction affect respiratory dysfunction associated with Forward head posture?

·        Secondary Objectives:

To study the impact of postural correction on PFT- PEF (Peak Expiratory flow),(FEV1/FVC), Maximal Inspiratory Pressure (MIP), EMG (upper trapezius, sternocleidomastoid, scalene muscles, neck erector spinae, diaphragm)

  1. Material and Methods

a.      Study Design: Quasi- experimental

b.      Sample size and method: 42,

Randomized sampling

c.      Enrolment period:

d.      Total Study duration: 6 months post IEC

e.      Inclusion and exclusion criteria:

 INCLUSION CRITERIA:

·        CVA <50 degreeCRA <20 degree

·        Neck Disability Index (NDI)  between 28-45%

·        Age criteria 21-40

·        Male, female

·        Individuals using a smartphone for more than four hours a day who rated their ‘worst pain over the last 24-h’ as moderate using the visual analogue scale (VAS).

·        Use of screen time calculator application in smart phone

 EXCLUSION CRITERIA

·        Previous history of neck or back surgery ,neurological signs, rheumatoid arthritis, currently using muscle relaxation medication

·        Scoliosis 0f 20 degree or above

·        Cervical trauma, cervical spine surgery, asthma, cancer history, heart disease, uncontrolled hypertension, systemic disorders, smoking history, oral corticosteroids, antibiotics within one  month

·        Non- smoking

 f.       Study Procedures:

g.      Assessment tools:

h.        Statistical Analysis Plan (SAP):

·        Independent t-test will be used to calculate the differences in Peak Expiratory flow, Maximal Inspiratory Pressure, FEV1/FVC value and Root Mean Square (EMG) and Chi-square test for categorical data will be done to test the homogeneity of clinical and demographic characteristics of the participants of the experimental and control groups at baseline.

·        Descriptive statistics using mean ± SD or proportion will be done for continuous variables. Median and inter-quartile ranges will be used for categorical data. Shapiro-Wilk test will be used to test the normality of the outcome variables.

·        Independent t-test or Mann Whitney U test will assess between group differences at two time points, baseline, at the end of week 4 depending on the normality of the data.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • CVA less than 50 degree CRA less than 20 degree Neck Disability Index (NDI) between 28-45 percent Individuals using a smartphone for more than four hours a day who rated their ‘worst pain over the last 24 hour as moderate using the visual analogue scale (VAS) Using screen time calculator in smart phone.

排除标准

  • Previous history of neck or back surgery ,neurological signs, rheumatoid arthritis, currently using muscle relaxation medication.
  • Scoliosis 0f 20 degree or above.
  • Cervical trauma, cervical spine surgery, asthma, cancer history, heart disease, uncontrolled hypertension, systemic disorders, smoking history, oral corticosteroids, antibiotics within one month.

结局指标

主要结局

Peak Expiratory Flow(PEF)

时间窗: 30 minutes

FEV1/FVC(Forced expiratory volume /Forced Vital Capacity, Maximal Inspiratory Pressure

时间窗: 30 minutes

次要结局

  • Electromyography-Baseline and activity levels (RMS-Root Mean Square, Maximum Voluntary Contraction) of Trapezius, scalene, sternocleidomastoid, diaphragm

研究者

发起方
Indian Spinal Injuries CentreInstitute of Rehabilitation Sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Disha Bhattacharya

Indian Spinal Injuries Centre-IRS

研究点 (1)

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