Forward Head PostureNCT05032274
Effect of Postural Realignment on Postural Stability and Visual Reliance in Older Adults
A study testing Home-based Exercise Program in people with Forward Head Posture, run by Loma Linda University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Forward Head Posture
- What is being tested?
- Home-based Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 3 Mar 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 65 to 74 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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+)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Home-based Exercise Program on Visual Reliance, Cervical Spine Proprioception, and Postural Stability in Older Adults With Forward Head Posture
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.
Read the detailed description
This study will have a sample size of 50 older adults (males and females) aged 65-74 years old with FHP. This sample size will provide us with enough power to detect the needed effect size (medium effect size). The estimated attrition rate is 20%. The participants will be recruited from the local community through flyers, e-mails, and word of mouth. Study flyers will be delivered to physical therapy clinics, physician offices, and support groups with verbal description for further explanations. Potential participants who respond to the emails or flyers will be provided with a verbal description of the study.
The study will be conducted in the Department of Physical Therapy, Loma Linda University, Loma Linda. Hard copies will be stored in a locked file cabinet in a locked research laboratory and computer data will be stored on an encrypted computer in a locked research laboratory.
All data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 27.0. For quantitative data, the investigators will use the General Linear Model (Mixed Factorial Analysis of Variance) and Correlation Analysis (Pearson's Correlation). Also, a statistician will be consulted to accurately analyze and interpret results. The alpha level will be set at 0.05.
Efforts will be made to keep participants' personal information confidential, but the investigators cannot guarantee absolute confidentiality. The investigators will use a pseudonym throughout the study for all recorded data so participant's actual name will not be used. Participants will not be identified by name in any publications describing the results of this study. Data in hard copy will be kept in a locked file cabinet in a locked office and electronic data will be password protected.
- Conditions
- Forward Head Posture
- Being tested
- Home-based Exercise Program
- Keywords
- Forward head posture, Balance, Home exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | The study will include one group and each participant will perform home-based exercise for 8-weeks. Receives: Other: Home-based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cervical Joint Position Error (JPE)
Ability to relocate one's head and neck to pre-determined neutral position recorded in degrees.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20-25 minutes
Secondary outcomes (1)
Change in Balance Confidence
Subjective confidence in performing functional activities without losing balance. Activities-Specific Balance Confidence (ABC-6) scale will be used to measure balance confidence. ABC-6 scale ranges from 0 to 100 where 0 represents "no confidence" and 100 represents "complete confidence.
Measured: ABC-6 will be conducted twice (pre vs post-intervention) and each time will take approximately 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start12 Jan 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Forward Head PostureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- single group pretest-posttest design
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric G Johnson, DSc, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032274
- Sponsor's protocol ID
- 5210004
- Status last verified
- Oct 2024
- First submitted
- 16 Aug 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 25687664Sheikhhoseini 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.
PubMed 30107937Lee 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.
PubMed 25435690Silva 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.
PubMed 23219786
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home-based Exercise Program on Visual Reliance, Cervical Spine Proprioception, and Postural Stability in Older Adults With Forward Head Posture
- ClinicalTrials.gov ID
- NCT05032274
- Acronym / sponsor ID
- 5210004
- Conditions
- Forward Head Posture
- Keywords
- Forward head posture, Balance, Home exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will have a sample size of 50 older adults (males and females) aged 65-74 years old with FHP. This sample size will provide us with enough power to detect the needed effect size (medium effect size). The estimated attrition rate is 20%. The participants will be recruited from the local community through flyers, e-mails, and word of mouth. Study flyers will be delivered to physical therapy clinics, physician offices, and support groups with verbal description for further explanations. Potential participants who respond to the emails or flyers will be provided with a verbal description of the study.
The study will be conducted in the Department of Physical Therapy, Loma Linda University, Loma Linda. Hard copies will be stored in a locked file cabinet in a locked research laboratory and computer data will be stored on an encrypted computer in a locked research laboratory.
All data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 27.0. For quantitative data, the investigators will use the General Linear Model (Mixed Factorial Analysis of Variance) and Correlation Analysis (Pearson's Correlation). Also, a statistician will be consulted to accurately analyze and interpret results. The alpha level will be set at 0.05.
Efforts will be made to keep participants' personal information confidential, but the investigators cannot guarantee absolute confidentiality. The investigators will use a pseudonym throughout the study for all recorded data so participant's actual name will not be used. Participants will not be identified by name in any publications describing the results of this study. Data in hard copy will be kept in a locked file cabinet in a locked office and electronic data will be password protected.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group pretest-posttest design
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Other: Home-based Exercise ProgramThe study will include one group and each participant will perform home-based exercise for 8-weeks. |
Who may qualify
- Ages
- 65 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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+)
Key exclusion criteria (10 listed)
- Neurologic deficits
- Disorders causing dizziness
- Cervical spine surgery
- Any falls in past six months
- Medications causing frequent dizziness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based Exercise ProgramThe 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. | Other | Single group |
Primary outcome
Change in Cervical Joint Position Error (JPE)
Time frame: JPE will be measured twice (pre vs post-intervention) and each time will take approximately 25-30 minutes.
Ability to relocate one's head and neck to pre-determined neutral position recorded in degrees.
Change in Active Cervical Spine Range of Motion (AROM)
Time frame: AROM will be measured twice (pre vs post-intervention) and each time will take approximately 5 minutes
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.
Change in Postural Stability
Time frame: Postural stability will be measured twice (pre vs post-intervention) and each time will take approximately 25 minutes
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.
Change in Forward Head Angle (FHA)
Time frame: FHA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.
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.
Change in Forward Shoulder Angle (FSA)
Time frame: FSA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.
FSA is the angle between a line extending from C7 to acromion and the vertical axis at C7. FSA will be measured in degrees.
Post-Intervention Structured Interview
Time frame: 20-25 minutes
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.
1 secondary outcome
Change in Balance Confidence
Time frame: ABC-6 will be conducted twice (pre vs post-intervention) and each time will take approximately 5 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 25687664Franz 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.
- Background: PubMed 30107937Sheikhhoseini 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.
- Background: PubMed 25435690Lee 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.
- Background: PubMed 23219786Silva 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.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric G Johnson, DSc principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Exercise Program in people with Forward Head Posture, run by Loma Linda 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 5 inclusion and 10 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 2 Oct 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 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 Cervical Joint Position Error (JPE) (time frame: JPE will be measured twice (pre vs post-intervention) and each time will take approximately 25-30 minutes.). The study lists 6 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 NCT05032274, which also lists 4 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 2 Oct 2024.