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Clinical Trials/CTRI/2025/11/097193
CTRI/2025/11/097193Not yet recruitingPhase 2/3

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

Indian Spinal Injuries CentreInstitute of Rehabilitation Sciences1 site in 1 country42 target enrollmentStarted: November 20, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
42
Locations
1
Primary Endpoint
Peak Expiratory Flow(PEF)

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Investigator Blinded

Eligibility Criteria

Ages
21.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

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.

Outcomes

Primary Outcomes

Peak Expiratory Flow(PEF)

Time Frame: 30 minutes

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

Time Frame: 30 minutes

Secondary Outcomes

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

Investigators

Sponsor
Indian Spinal Injuries CentreInstitute of Rehabilitation Sciences
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Disha Bhattacharya

Indian Spinal Injuries Centre-IRS

Study Sites (1)

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