Clinical trial NCT05032274: Effect of Postural Realignment on Postural Stability and Visual Reliance in Older Adults
Official title: Effect of Home-based Exercise Program on Visual Reliance, Cervical Spine Proprioception, and Postural Stability in Older Adults With Forward Head Posture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forward Head Posture
Keywords: Forward head posture
Balance
Home exercise program
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Maximum age (years): 74
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group pretest-posttest design
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Cervical Joint Position Error (JPE)
timeFrame: JPE will be measured twice (pre vs post-intervention) and each time will take approximately 25-30 minutes.
measure: Change in Active Cervical Spine Range of Motion (AROM)
timeFrame: AROM will be measured twice (pre vs post-intervention) and each time will take approximately 5 minutes
measure: Change in Postural Stability
timeFrame: Postural stability will be measured twice (pre vs post-intervention) and each time will take approximately 25 minutes
measure: Change in Forward Head Angle (FHA)
timeFrame: FHA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.
measure: Change in Forward Shoulder Angle (FSA)
timeFrame: FSA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.
measure: Post-Intervention Structured Interview
timeFrame: 20-25 minutes
Secondary outcomes:
measure: Change in Balance Confidence
timeFrame: ABC-6 will be conducted twice (pre vs post-intervention) and each time will take approximately 5 minutes.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Eric G Johnson, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.