NCT05032274

Brief Summary

The purpose of this investigator-initiated study is 1) to investigate correlation between cervical spine joint position error (JPE) and postural stability in asymptomatic older adults with forward head posture (FHP), 2) to examine the effect of a home-based exercise program on visual reliance and cervical spine proprioception for postural stability in asymptomatic older adults with FHP, 3) to study the effect of immediate postural correction on cervical spine JPE and active range of motion (AROM), and 4) to determine participant post-intervention perception of changes in FHP, postural stability and effect on quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

August 16, 2021

Last Update Submit

October 1, 2024

Conditions

Forward Head Posture

Keywords

Forward head postureBalanceHome exercise program

Outcome Measures

Primary Outcomes (6)

  • Change in Cervical Joint Position Error (JPE)

    Ability to relocate one's head and neck to pre-determined neutral position recorded in degrees.

    JPE will be measured twice (pre vs post-intervention) and each time will take approximately 25-30 minutes.

  • Change in Active Cervical Spine Range of Motion (AROM)

    Ability to actively move cervical spine in all six directions (flexion, extension, right and left rotation, right and left Lateral flexion). Cervical AROM will be measured in degrees.

    AROM will be measured twice (pre vs post-intervention) and each time will take approximately 5 minutes

  • Change in Postural Stability

    Ability to keep center of gravity within base of support under six different testing conditions and will be scored from 0-100 by the computer software. Higher scores indicate better postural stability.

    Postural stability will be measured twice (pre vs post-intervention) and each time will take approximately 25 minutes

  • Change in Forward Head Angle (FHA)

    FHA is the angle formed between a line extending from the tragus to C7 and a vertical axis at C7. FHA will be measured in degrees.

    FHA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.

  • Change in Forward Shoulder Angle (FSA)

    FSA is the angle between a line extending from C7 to acromion and the vertical axis at C7. FSA will be measured in degrees.

    FSA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.

  • Post-Intervention Structured Interview

    Post-intervention structured interview will be conducted using open-ended questions. Interviews will be recorded and transcribed verbatim. Transcriptions will be individually coded, and then group coded using qualitative research software.

    20-25 minutes

Secondary Outcomes (1)

  • Change in Balance Confidence

    ABC-6 will be conducted twice (pre vs post-intervention) and each time will take approximately 5 minutes.

Study Arms (1)

Single group

EXPERIMENTAL

The study will include one group and each participant will perform home-based exercise for 8-weeks.

Other: Home-based Exercise Program

Interventions

Home-based Exercise ProgramOTHER

The exercise program will include chink tuck and shoulder retraction exercises. The chin tuck exercise will be performed in standing position. The shoulder retraction exercise includes activation and strengthening components. The activation component will be performed in standing position and strengthening component will be performed in prone position.

Single group

Eligibility Criteria

Age65 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Older adults aged 65-74 years with forward head posture (FHP)
  • Live independently
  • No use of assistive devices for ambulation
  • Have interest in correcting misaligned posture
  • Normal Physical Activity Readiness Questionnaire (PAR-Q+)

You may not qualify if:

  • Neurologic deficits
  • Disorders causing dizziness
  • Cervical spine surgery
  • Any falls in past six months
  • Medications causing frequent dizziness
  • Any health care for neck, shoulder, or low back pain past 12 months
  • Greater than minimal neck pain as determined by the Visual Analogue Scale (VAS) \> 3/10
  • Neck Disability Index (NDI) \> 15%
  • Forward Head Angle (FHA) \< 46 degrees
  • Forward Shoulder Angle (FSA) \< 52 degrees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Related Publications (4)

  • Franz JR, Francis CA, Allen MS, O'Connor SM, Thelen DG. Advanced age brings a greater reliance on visual feedback to maintain balance during walking. Hum Mov Sci. 2015 Apr;40:381-92. doi: 10.1016/j.humov.2015.01.012. Epub 2015 Feb 14.

    PMID: 25687664BACKGROUND

  • Sheikhhoseini R, Shahrbanian S, Sayyadi P, O'Sullivan K. Effectiveness of Therapeutic Exercise on Forward Head Posture: A Systematic Review and Meta-analysis. J Manipulative Physiol Ther. 2018 Jul-Aug;41(6):530-539. doi: 10.1016/j.jmpt.2018.02.002. Epub 2018 Aug 11.

    PMID: 30107937BACKGROUND

  • Lee MY, Lee HY, Yong MS. Characteristics of cervical position sense in subjects with forward head posture. J Phys Ther Sci. 2014 Nov;26(11):1741-3. doi: 10.1589/jpts.26.1741. Epub 2014 Nov 13.

    PMID: 25435690BACKGROUND

  • Silva AG, Johnson MI. Does forward head posture affect postural control in human healthy volunteers? Gait Posture. 2013 Jun;38(2):352-3. doi: 10.1016/j.gaitpost.2012.11.014. Epub 2012 Dec 7.

    PMID: 23219786BACKGROUND

Study Officials

  • Eric G Johnson, DSc

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: single group pretest-posttest design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

September 2, 2021

Study Start

January 12, 2022

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

October 2, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data (IPD) available to other researchers.

Locations

US(1)