NCT06571253

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

August 22, 2024

Last Update Submit

September 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    6 weeks

  • 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.

    6 weeks

Study Arms (2)

Fiziu Digital Physiotherapy Platform Arm

EXPERIMENTAL

Participants 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).

Behavioral: Digital Exercise Intervention

Paper-Based Exercise Program Arm

EXPERIMENTAL

Participants 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.

Behavioral: Paper-Based Exercise Intervention

Interventions

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.

Fiziu Digital Physiotherapy Platform Arm

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.

Paper-Based Exercise Program Arm

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Kavacık, 34815, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 26476717BACKGROUND
  • 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.

    PMID: 35935117BACKGROUND
  • 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.

    PMID: 26957754BACKGROUND
  • 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.

    PMID: 11932856BACKGROUND
  • 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.

    PMID: 5727966BACKGROUND
  • 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.

    PMID: 9861410BACKGROUND
  • 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.

    PMID: 10832142BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seda Gözener Canbülbül, PhD(c)

    İstanbul Medipol Üniversitesi Kavacık Güney Kampüs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 26, 2024

Study Start

March 1, 2023

Primary Completion

April 15, 2023

Study Completion

June 1, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations