Effect of Postural Realignment on Postural Stability and Visual Reliance in Older Adults

September 6, 2023 updated by: Loma Linda University

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eric G Johnson, DSc
  • Phone Number: 47471 909-558-4632
  • Email: ejohnson@llu.edu

Study Locations

    • California
      • Loma Linda, California, United States, 92350
        • Recruiting
        • Loma Linda University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 74 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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.
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)
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.
AROM will be measured twice (pre vs post-intervention) and each time will take approximately 5 minutes
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.
Postural stability will be measured twice (pre vs post-intervention) and each time will take approximately 25 minutes
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.
FHA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.
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.
FSA will be measured twice (pre vs post-intervention) and each time will take approximately 13 minutes.
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.
20-25 minutes

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric G Johnson, DSc, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

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)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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