- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05032274
Effect of Postural Realignment on Postural Stability and Visual Reliance in Older Adults
Effect of Home-based Exercise Program on Visual Reliance, Cervical Spine Proprioception, and Postural Stability in Older Adults With Forward Head Posture
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric G Johnson, DSc
- Phone Number: 47471 909-558-4632
- Email: ejohnson@llu.edu
Study Locations
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California
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Loma Linda, California, United States, 92350
- Recruiting
- Loma Linda University
-
Contact:
- Eric Johnson
- Phone Number: 47471 909-558-4632
- Email: ejohnson@llu.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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+)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single group
The study will include one group and each participant will perform home-based exercise for 8-weeks.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Ability to relocate one's head and neck to pre-determined neutral position recorded in degrees.
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JPE will be measured twice (pre vs post-intervention) and each time will take approximately 25-30 minutes.
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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
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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.
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AROM will be measured twice (pre vs post-intervention) and each time will take approximately 5 minutes
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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.
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Postural stability will be measured twice (pre vs post-intervention) and each time will take approximately 25 minutes
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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.
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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.
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FHA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.
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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.
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FSA is the angle between a line extending from C7 to acromion and the vertical axis at C7. FSA will be measured in degrees.
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FSA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.
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Post-Intervention Structured Interview
Time Frame: 20-25 minutes
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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.
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20-25 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Balance Confidence
Time Frame: ABC-6 will be conducted twice (pre vs post-intervention) and each time will take approximately 5 minutes.
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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.
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ABC-6 will be conducted twice (pre vs post-intervention) and each time will take approximately 5 minutes.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric G Johnson, DSc, Loma Linda University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5210004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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