An interventional study of Education for Behavior Modification and Corrective Exercise Program in Postural; Defect, sponsored by Liberty University. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Liberty University · Not applicable, Interventional, and Prevention
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.
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.
Liberty University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
PE 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.
Behavioral: Education for Behavior Modification
This 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.
Behavioral: Corrective Exercise Program
This 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.
Behavioral: Corrective Exercise Program
Participants in the CG did not receive an intervention.
Please see arm description for a detailed description of the intervention
Please see arm description for a detailed description of the intervention
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.
Time frame: Baseline: On day 1 of study enrollment; Post-Intervention: Within 5 days after the end of the 4 week intervention period
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.
Time frame: Assessed at the start of week 3
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.
Time frame: Within 5 days after the end of the 4 week intervention period.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All collected IPD that underlie results in a publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Starting immediately after publication. No end date.
Access criteria: The primary investigator will review requests received by email. Requests granted to researchers and/or research institutions for the purpose of future research studies. The Liberty University Institutional Review Board will also be notified prior to releasing IPD and/or supporting information. Rather than a URL, individuals interested in IPD and/or supporting information will contact the primary investigator by email, which will be provided in the publication along with a statement about the plan to share IPD.
Ran from Aug 2021 to primary completion in Nov 2021, 2 months.
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