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Postural; DefectNCT05321654

Effects of Postural Education or Corrective Exercise on Forward Head Posture

A study testing Education for Behavior Modification and Corrective Exercise Program in people with Postural; Defect, run by Liberty University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized control trial examined the effects of postural education or corrective exercise intervention on the craniovertebral angle (CVA) in young adults with forward head posture (FHP). Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Postural; Defect
What is being tested?
Education for Behavior Modification and Corrective Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteUnited States
Study dates
26 Aug 2021to 4 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Completion of informed consent
  • Craniovertebral angle ≤ 53 degrees
  • Self-rating of Transtheoretical Model stage of change stage ≥ 3/5

Who cannot join

  • Any musculoskeletal injury to the head, shoulders, or spine within the last six months
  • Diagnosis of pathology related to the cervical spine, thoracic spine, or upper extremities
  • Non-clearance for physical activity based on results of the 2020 PAR-Q+ questionnaire

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Liberty University

    Lynchburg, Virginia, 24515

Other trials in United States

About this study

Official title: The Effects of Postural Education or Corrective Exercise Intervention on the Craniovertebral Angle in Young Adults With Forward Head Posture: A Randomized Controlled Trial

This randomized control trial examined the effects of postural education or corrective exercise intervention on the craniovertebral angle (CVA) in young adults with forward head posture (FHP). The objectives were 1: to investigate whether or not a corrective exercise program (CEP) consisting of self-myofascial release (SMR) + stretching; a CEP consisting of SMR + stretching + strengthening; or postural education (PE) had an effect on the CVA; 2. to determine which intervention yielded the greatest postural enhancement if a positive effect was observed in more than one intervention. *[note: SMR is a technique involving the self-application of pressure to fascia and muscle tissue for the purpose of enhancing flexibility, reducing muscle soreness, and influencing muscle relaxation]. It was hypothesized that 4 weeks after receiving either CEP intervention or PE there would be a significant change in the CVA compared to a control group; and that there would be an intervention more effective than the others for improving the CVA. The null hypotheses were: there would be no CVA change after intervention in any of the groups; and there will be no intervention more effective than another for improving the CVA.

Read the detailed description

A total of 94 participants responded to invitations to voluntarily participate and completed the Physical Activity Readiness Questionnaire (PAR-Q+), followed by a questionnaire to rate their current stage of change (SOC) from the Transtheoretical Model adapted to assess exercise/postural modification behavior change (this will be discussed further in eligibility section). On this questionnaire, participants also responded to a yes/no question regarding if they have had a recent injury to their head, shoulders, or spine; or have ever been diagnosed with a pathology related to their cervical/thoracic spine or extremities, as part of exclusion criteria for the study. Participants then underwent a head posture screening performed by the primary investigator who is a licensed physical therapist in the Liberty University Biomechanics \& Motion Analysis Laboratory with the use of photogrammetry (use of a digital camera and software to measure posture) as described below.

Participants were asked to arrive at the lab wearing either a tank top or t-shirt, as well as to have their hair tied back if necessary. Height and weight were measured using a digital scale (Health-o-meter Professional, model 500KL, McCook, IL). Participants were instructed to sit comfortably on a stool with hands resting approximately two-thirds down their thighs with palms supinated and feet flat on the ground with hips and knees at 90 degrees; and to look straight ahead at an opposite wall in the laboratory. A digital camera (Canon Powershot, model SX540, Tokyo, Japan) was mounted and leveled on a tripod (Manfrotto, model 055, Cassola, IT) and placed three meters away from the subject. Two photographs were taken of participant's posture. Immediately after data capture, image files were uploaded into Kinovea video analysis software (version 8.15) for CVA assessment. CVA assessment will be discussed further in outcome measures section.

Seventy-nine participants met inclusion criteria (discussed in detail in future section) and were enrolled in the study. Randomization of participant group assignments was completed by the PI using a block randomization generator. Utilizing a sequence created by the block randomizer, the PI placed participants who met inclusion criteria into one of four groups: postural education (PE; n = 20), self-myofascial release + stretching (SMRS; n = 20), self-myofascial release + stretching + strengthening (SMRSS; n = 19), and control group (CG; n = 20). Details of these groups will be provided in future sections. A hard-copy of the sequence generator report was kept concealed in a manila folder and was only opened by the PI during group delegation.

Intervention duration was 4 weeks. Two weeks into the study, participants in intervention groups completed a mid-study questionnaire to assess intervention compliance. At the end of the study (after the completion of 4 weeks) participants in intervention groups completed a post-study questionnaire to assess intervention compliance. All study participants were asked to return back to the Biomechanics laboratory after the completion of the 4 week intervention period to undergo follow-up posture screening, which followed the same posture assessment procedures as described above.

Declarations of interest: This study was part of the requirements for completion of a Ph.D. dissertation (Concordia University Chicago) by David Titcomb, DPT.

Conflicts of interest: none.

Being tested
Education for Behavior Modification, Corrective Exercise Program
Keywords
Forward Head Posture, Craniovertebral Angle, Corrective Exercise Program, Postural Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education for Behavior ModificationBehavioural

    Please see arm description for a detailed description of the intervention

  • Corrective Exercise ProgramBehavioural

    Please see arm description for a detailed description of the intervention

Study groups in NCT05321654
Study groupRoleWhat they receive
Posture Education (PE) GroupExperimentalPE group members received a 20-minute in-person one-on-one standardized educational session by a research team member in the laboratory on the following topics: health risks associated with forward head posture; postural guidelines for using mobile electronic devices, desktop computers, and laptop computers; as well as rest break guidelines. Participants were asked to adhere to the postural guidelines provided in the educational session for the next 4 weeks.
Receives: Behavioral: Education for Behavior Modification
Self-Myofascial Release + Stretching (SMRS) GroupExperimentalThis group applied self-myofascial release (SMR) to their thoracic spine with a myofascial roller for 30 sec., then 6 repetitions of myofascial rolling for 90 sec. They applied SMR for 30 sec. to their neck flexors and extensors using their fingertips. They applied SMR to the upper trapezius and pectoralis for 30 sec using a soft tissue mobilization tool. For the first 2 weeks, they performed SMR 3x/wk. During wks. 3 and 4, they progressed SMR to 5 days/wk. Group members also performed stretching to these same muscles after SMR 3 days/wk for the first 2 weeks of the study, progressing to 5 days/wk during weeks 3 and 4.
Receives: Behavioral: Corrective Exercise Program
Self-Myofascial Release + Stretching + Strengthening (SMRSS) GroupExperimentalThis group performed the same protocol as SMRS group, as well as include the following strengthening exercises: the supine chin tuck (SCT), upper thoracic-lower cervical extension (UTLCE) using an exercise band that provided 5.5 pounds of resistance, and a single-arm row with trunk rotation (SARTR) using exercise tubing that provided 20 pounds of resistance. The SCT was progressed in 3 phases: Week 1: chin tuck held 2 sec., 5 reps. Week 2: same as week 1, but included us of a towel roll placed under the head. Wks. 3 and 4: chin tuck with head lift 1 in., 2 sec. hold. UTLCE: neck extension with exercise band, held 2 sec. SARTR: single arm row with trunk rotation was performed in a controlled and fluid manner using a self-selected speed. The UTLCE and SARTR were performed with 1 X 10 reps for wks 1-2 and progressed to 2 X10 reps in wks 3-4. Strengthening exercises were performed 3x/wk. for 4 wks.
Receives: Behavioral: Corrective Exercise Program
Control Group (CG)No interventionParticipants in the CG did not receive an intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Craniovertebral Angle after 4 weeks

    The angle between the intersection of two lines drawn on the photograph: the first line drawn from the tragus of the ear to the spinous process of C7 vertebrae and the second line drawn horizontally through C7 spinous process. In this study, a second researcher directly observed the primary investigator performing each CVA assessment, as well as provided verbal agreement with the accuracy of angle measurement. For each participant, the CVA was derived by taking the mean of two CVA measurements that were assessed on the captured photographs.

    Measured: Baseline: On day 1 of study enrollment; Post-Intervention: Within 5 days after the end of the 4 week intervention period

Secondary outcomes (2)
  1. Midpoint Intervention Compliance

    On a questionnaire, participants were asked to rate their compliance with their assigned intervention guidelines. Consistent. 75% adherence to guidelines; Moderately Consistent. 50 to 75% adherence to guidelines; Inconsistent. Less than 50% adherence to guidelines.

    Measured: Assessed at the start of week 3

  2. Endpoint Intervention Compliance

    On a questionnaire, participants were asked to rate their compliance with their assigned intervention guidelines. Consistent. 75% adherence to guidelines; Moderately Consistent. 50 to 75% adherence to guidelines; Inconsistent. Less than 50% adherence to guidelines.

    Measured: Within 5 days after the end of the 4 week intervention period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start26 Aug 2021
  3. Primary completion4 Nov 2021
  4. Study completion4 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective parallel randomized controlled trial with repeated measures
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321654
Sponsor's protocol ID
IRB-FY20-21-1073
Other IDs
UR2201
Status last verified
Apr 2022
First submitted
18 Mar 2022
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD that underlie results in a publication.

Publications

  • Abdelhameed AA, Abdel-Aziem AA. Exercise training and postural correction improve upper extremity symptoms among touchscreen smartphone users. Hong Kong Physiother J. 2016 Sep 7;35:37-44. doi: 10.1016/j.hkpj.2016.06.001. eCollection 2016 Dec.

    PubMed 30931032
  • Bayattork M, Seidi F, Minoonejad H, McClure P, Mozafaripoor E. Intra-rater and inter-rater reliability and agreement of the scapular dyskinesis test in young men with forward head and round shoulder posture. J Rehabil. Sci. 2019 Dec 10;6(4):169-173. https://doi.org/10.30476/JRSR.2019.82944.1037

  • Carter SE, Draijer R, Holder SM, Brown L, Thijssen DHJ, Hopkins ND. Regular walking breaks prevent the decline in cerebral blood flow associated with prolonged sitting. J Appl Physiol (1985). 2018 Sep 1;125(3):790-798. doi: 10.1152/japplphysiol.00310.2018. Epub 2018 Jun 7.

    PubMed 29878870
  • Cuellar JM, Lanman TH. "Text neck": an epidemic of the modern era of cell phones? Spine J. 2017 Jun;17(6):901-902. doi: 10.1016/j.spinee.2017.03.009. Epub 2017 Mar 20. No abstract available.

    PubMed 28336483
  • Engelmann C, Schneider M, Kirschbaum C, Grote G, Dingemann J, Schoof S, Ure BM. Effects of intraoperative breaks on mental and somatic operator fatigue: a randomized clinical trial. Surg Endosc. 2011 Apr;25(4):1245-50. doi: 10.1007/s00464-010-1350-1. Epub 2010 Sep 11.

    PubMed 20835716
  • Fahmy R. NASM Essentials of corrective exercise training. 2nd ed. Burlington, Massachusetts: Jones & Bartlett Learning; 2022.

  • Gustafsson E. Ergonomic recommendations when texting on mobile phones. Work. 2012;41 Suppl 1:5705-6. doi: 10.3233/WOR-2012-0925-5705.

    PubMed 22317659
  • Hansraj KK. Assessment of stresses in the cervical spine caused by posture and position of the head. Surg Technol Int. 2014 Nov;25:277-9.

    PubMed 25393825
  • Kalichman L, Bulanov N, Friedman A. Effect of exams period on prevalence of Myofascial Trigger points and head posture in undergraduate students: Repeated measurements study. J Bodyw Mov Ther. 2017 Jan;21(1):11-18. doi: 10.1016/j.jbmt.2016.04.003. Epub 2016 Apr 7.

    PubMed 28167166
  • Kar G, Hedge A. Effect of workstation configuration on musculoskeletal discomfort, productivity, postural risks, and perceived fatigue in a sit-stand-walk intervention for computer-based work. Appl Ergon. 2021 Jan;90:103211. doi: 10.1016/j.apergo.2020.103211. Epub 2020 Aug 17.

    PubMed 32818838
  • Kim BB, Lee JH, Jeong HJ, Cynn HS. Effects of suboccipital release with craniocervical flexion exercise on craniocervical alignment and extrinsic cervical muscle activity in subjects with forward head posture. J Electromyogr Kinesiol. 2016 Oct;30:31-7. doi: 10.1016/j.jelekin.2016.05.007. Epub 2016 May 24.

    PubMed 27261928
  • Kim SY, Koo SJ. Effect of duration of smartphone use on muscle fatigue and pain caused by forward head posture in adults. J Phys Ther Sci. 2016 Jun;28(6):1669-72. doi: 10.1589/jpts.28.1669. Epub 2016 Jun 28.

    PubMed 27390391
  • Kuroda Y, Sato Y, Ishizaka Y, Yamakado M, Yamaguchi N. Exercise motivation, self-efficacy, and enjoyment as indicators of adult exercise behavior among the transtheoretical model stages. Glob Health Promot. 2012 Mar;19(1):14-22. doi: 10.1177/1757975911423073. Epub 2012 Feb 14.

    PubMed 24801311
  • Lau KT, Cheung KY, Chan KB, Chan MH, Lo KY, Chiu TT. Relationships between sagittal postures of thoracic and cervical spine, presence of neck pain, neck pain severity and disability. Man Ther. 2010 Oct;15(5):457-62. doi: 10.1016/j.math.2010.03.009.

    PubMed 20430685
  • Lee DY, Nam CW, Sung YB, Kim K, Lee HY. Changes in rounded shoulder posture and forward head posture according to exercise methods. J Phys Ther Sci. 2017 Oct;29(10):1824-1827. doi: 10.1589/jpts.29.1824. Epub 2017 Oct 21.

    PubMed 29184298

Questions about this trial

What is this clinical trial studying?

A study testing Education for Behavior Modification and Corrective Exercise Program in people with Postural; Defect, run by Liberty University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Craniovertebral Angle after 4 weeks (time frame: Baseline: On day 1 of study enrollment; Post-Intervention: Within 5 days after the end of the 4 week intervention period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05321654, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.

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