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Cervical PainNCT06571253

Comparison of Online and Paper-Based Exercise Efficacy in Forward Head Posture

A study testing Digital Exercise Intervention and Paper-Based Exercise Intervention in people with Cervical Pain, run by Medipol University at 1 site in Turkey (Türkiye).

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

Proper posture is a musculoskeletal balance that minimizes stress on the body and is a key component of orthopedic physical examination. Poor posture, including forward head posture (FHP) and round shoulders, can develop as early as puberty and is exacerbated by prolonged use of smartphones and visual display… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Cervical Pain
What is being tested?
Digital Exercise Intervention and Paper-Based Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2023to 1 Jun 2023
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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • participants aged 18-35 years,
  • possessing internet access,
  • exhibiting a forward head posture (CVA < 50°)

Who cannot join

  • participants under 18 or over 35 years of age,
  • lacking internet access,
  • having a history of head, neck, and shoulder injuries.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, Kavacık, 34815

Other trials in Turkey (Türkiye)

About this study

Official title: The Comparison of the Efficacy of Online Exercise Prescriptions Delivered Via the Fiziu Digital Physiotherapy Platform and Conventional Paper-Based Exercises in Individuals with Forward Head Posture

Proper posture is a musculoskeletal balance that minimizes stress on the body and is a key component of orthopedic physical examination. Poor posture, including forward head posture (FHP) and round shoulders, can develop as early as puberty and is exacerbated by prolonged use of smartphones and visual display terminals (VDT), leading to neck and shoulder fatigue and degenerative spine changes. FHP, a common postural issue in the sagittal plane, is associated with thoracic hyperkyphosis and can negatively impact respiratory function by reducing thoracic expansion and lung capacity. FHP also contributes to various musculoskeletal issues, such as temporomandibular disorders, myofascial pain syndrome, and cervicogenic headaches, by increasing biomechanical strain on the posterior neck muscles. Kendall and colleagues describe FHP as a forward positioning of the head, with shortened neck extensors and weakened anterior vertebral neck flexors, leading to muscle fiber damage over time. FHP can be measured using methods like craniovertebral angle (CVA), which is a reliable indicator of FHP severity. Exercise therapy, including strengthening, stretching, and proprioceptive exercises, is recommended to correct FHP and improve postural alignment, potentially enhanced by scapular stabilization exercises. The rise of telehealth presents a promising avenue for treating FHP through accessible and effective telerehabilitation methods. This study aimed to compare the effects of a 6-week home exercise program implemented via the Fiziu digital exercise platform and a traditional paper-based program on FHP and to compare the results between the two groups.

Read the detailed description

This study aimed to compare the effects of a corrective exercise program delivered via the Fiziu Digital Physiotherapy Platform with those delivered through a paper-based exercise program on volunteers with forward head posture (FHP). The primary objective was to evaluate the impact of these programs on joint range of motion (ROM) and craniocervical angle (CVA) in individuals with FHP and to assess the therapeutic efficacy of a consistent exercise regimen. Additionally, the study sought to determine whether there were differences in outcomes between the digital and paper-based methods, particularly in terms of usability and efficiency.

The study utilized an experimental research design, involving a total of 40 participants, with 20 receiving exercises via the Fiziu platform and 20 following paper-based programs. The intervention lasted six weeks, during which time participants' cervical flexion/extension, lateral flexion (right and left), and rotation (right and left) were measured using a goniometer. The CVA, which represents the angle between the head and the cervical region, was also measured, alongside neck function assessed by the Neck Disability Index (NDI).

Measurements were conducted in a seated position. For cervical flexion and extension, the goniometer's fixed arm was aligned vertically with the floor, with the central point on the C7 vertebra's spinous process. The movable arm was positioned at the external auditory meatus. Participants were instructed to perform maximum flexion and extension movements, and the final angle was recorded. Lateral flexion was measured by placing the goniometer's pivot point on C7, the fixed arm parallel to the floor, and the movable arm aligned with the external occipital protuberance. Participants were asked to bring their ears toward their shoulders, and the final angle was noted. Cervical rotation was measured by placing the goniometer on the vertex of the head, with the fixed arm parallel to the floor and aligned with the nose, and the movable arm following the tip of the nose. Participants rotated their heads to the right and left, and the final angles were recorded.

For CVA measurement, participants maintained a neutral neck position. The goniometer's pivot point was placed on C7, with the fixed arm parallel to the floor and the movable arm aligned with the tragus of the ear. The angle between these two points was recorded.

The NDI was used to measure neck function, which evaluates a person's capacity to perform daily tasks across ten categories: pain intensity, lifting, concentration, reading, headaches, self-care, driving, work, sleep, and recreation. Each category is scored from 0 to 5, with higher scores indicating greater disability.

All measurements were repeated at the end of the study to assess the effectiveness of the interventions.

Inclusion criteria were as follows: participants aged 18-35 years, possessing internet access, and exhibiting a forward head posture (CVA < 50°). Exclusion criteria included: participants under 18 or over 35 years of age, lacking internet access, or having a history of head, neck, or shoulder injuries or surgeries.

The results demonstrated that both the digital and paper-based exercise programs effectively improved joint ROM and CVA in participants with FHP. However, no significant differences were found between the two groups in terms of their impact on CVA. Despite this, the Fiziu Digital Physiotherapy Platform was found to be more user-friendly and efficient compared to the traditional paper-based method, suggesting that digital platforms may offer a practical alternative for delivering therapeutic exercises, especially in telemedicine contexts.

This study fills a gap in the literature by providing insights into the effectiveness of digital exercise platforms for managing FHP, contributing to the broader discussion on the use of new technologies in physical therapy and rehabilitation.

Conditions
Cervical Pain
Being tested
Digital Exercise Intervention, Paper-Based Exercise Intervention
Medical subject headings
Neck Pain

What participants receive

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

  • Digital Exercise InterventionBehavioural

    Participants in this intervention arm used the Fiziu Digital Physiotherapy Platform. This digital platform provided a structured 6-week corrective exercise program through visual and auditory-guided videos. The intervention included interactive features such as reminders and progress tracking to enhance adherence and engagement.

  • Paper-Based Exercise InterventionBehavioural

    Participants in this intervention arm followed a traditional paper-based exercise program. This included printed exercise instructions and illustrations for a 6-week period. The program was designed to mimic standard physical therapy exercises without digital support.

Study groups in NCT06571253
Study groupRoleWhat they receive
Fiziu Digital Physiotherapy Platform ArmExperimentalParticipants in this arm received a 6-week corrective exercise program delivered via the Fiziu Digital Physiotherapy Platform. The program included guided exercise videos, visual and auditory instructions, and automated reminders to ensure adherence. This arm was designed to evaluate the effectiveness of digital exercise delivery in improving forward head posture (FHP).
Receives: Behavioral: Digital Exercise Intervention
Paper-Based Exercise Program ArmExperimentalParticipants in this arm followed a traditional paper-based exercise program for 6 weeks. The program included written instructions and images illustrating the exercises. This arm served as a comparison to evaluate the effectiveness of the traditional exercise delivery method against the digital platform.
Receives: Behavioral: Paper-Based Exercise Intervention

What is being measured

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

  1. Cervical Joint Range of Motion (ROM)

    The range of motion of the cervical spine will be measured in flexion, extension, lateral flexion (both right and left), and rotation (both right and left) using a goniometer. These measurements assess improvements in the mobility of the neck, which is directly affected by forward head posture (FHP).

    Measured: 6 weeks

  2. Craniocervical Angle (CVA)

    The craniocervical angle, defined as the angle between the horizontal line through the external auditory meatus and the line through the 7th cervical vertebra (C7), will be measured using a goniometer. This angle provides an indicator of the severity of FHP.

    Measured: 6 weeks

Timeline

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

  1. First posted26 Aug 2024
  2. Study start1 Mar 2023
  3. Primary completion15 Apr 2023
  4. Study completion1 Jun 2023

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
This clinical trial employed a randomized controlled design to investigate the effects of a corrective exercise program delivered via the Fiziu Digital Physiotherapy Platform compared to a paper-based exercise program on forward head posture (FHP) in a cohort of adult volunteers.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571253
Sponsor's protocol ID
İMU-SEDAGOZENER-003
Status last verified
Sep 2024
First submitted
22 Aug 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shaghayegh Fard B, Ahmadi A, Maroufi N, Sarrafzadeh J. Evaluation of forward head posture in sitting and standing positions. Eur Spine J. 2016 Nov;25(11):3577-3582. doi: 10.1007/s00586-015-4254-x. Epub 2015 Oct 17.

    PubMed 26476717
  • Mylonas K, Tsekoura M, Billis E, Aggelopoulos P, Tsepis E, Fousekis K. Reliability and Validity of Non-radiographic Methods of Forward Head Posture Measurement: A Systematic Review. Cureus. 2022 Aug 5;14(8):e27696. doi: 10.7759/cureus.27696. eCollection 2022 Aug.

    PubMed 35935117
  • Jung SI, Lee NK, Kang KW, Kim K, Lee DY. The effect of smartphone usage time on posture and respiratory function. J Phys Ther Sci. 2016 Jan;28(1):186-9. doi: 10.1589/jpts.28.186. Epub 2016 Jan 30.

    PubMed 26957754
  • Szeto GP, Lee R. An ergonomic evaluation comparing desktop, notebook, and subnotebook computers. Arch Phys Med Rehabil. 2002 Apr;83(4):527-32. doi: 10.1053/apmr.2002.30627.

    PubMed 11932856
  • Smithwick W 3rd, Gertner HR Jr, Zuidema GD. Injection of Hypaque (sodium diatrizoate) in the management of abdominal stab wounds. Surg Gynecol Obstet. 1968 Dec;127(6):1215-24. No abstract available.

    PubMed 5727966
  • van der Torn M, Thuma PE, Mabeza GF, Biemba G, Moyo VM, McLaren CE, Brittenham GM, Gordeuk VR. Loading dose of quinine in African children with cerebral malaria. Trans R Soc Trop Med Hyg. 1998 May-Jun;92(3):325-31. doi: 10.1016/s0035-9203(98)91032-x.

    PubMed 9861410
  • Mininni N. [The ethics of appropriateness and the appropriateness of ethics. Comments on a current topic of which we know little and which we discuss even less]. Ital Heart J Suppl. 2000 Apr;1(4):543-6. Italian.

    PubMed 10832142

Questions about this trial

What is this clinical trial studying?

A study testing Digital Exercise Intervention and Paper-Based Exercise Intervention in people with Cervical Pain, run by Medipol University at 1 site in Turkey (Türkiye).

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 19 Sep 2024. 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 Turkey (Türkiye). 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?

Cervical Joint Range of Motion (ROM) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT06571253, which also lists 7 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 19 Sep 2024.

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