Older Adult Traditional Balance Training vs Traditional Balance Training Plus Neck Strengthening

This study promotes greater understanding of factors impacting balance and how neck strength alters specific aspects of impaired balance. This study will help physical therapist protocols target a wholistic approach to treat fall risk individuals.

Study Overview

• Status: Not yet recruiting
• Conditions: Aging; Fall Injury Prevention; At Fall Risk
• Intervention / Treatment: Other: Neck Strengthening Exercises

Detailed Description

This study will use an interventional neck strengthening exercises along with physical therapist standard of care for balance for community dwelling older adults at fall risk.

The study has three aims: (1) evaluate the effects of a 6-week neck strengthening intervention on sensorimotor function in community-dwelling older adults at risk for falls, (2) examine the impact of neck strengthening on functional mobility and clinical balance performance, and (3) determine the effect of neck strengthening on psychosocial outcomes related to fall risk.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail Aultz; Phone Number: 2088412279; Email: aa425625@ohio.edu

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University
      • Principal Investigator: Melissa Anderson
      • Contact: Abigail Aultz; Phone Number: 2088412279; Email: aa425625@ohio.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 65 + for age appropriate for Medicare-based guidelines
• No previous upper cervical spine surgery
• Intracranial bleed within the last 6 months
• No recent orthopedic surgical intervention or injury that limits weight-bearing capacity on one side in the past 6 months
• Able to stand for at least 30 seconds without any sort of upper-extremity assistance

Exclusion Criteria:

• legally blind
• taking meclizine
• unable to follow simple motor commands

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neck Strengthening Intervention; Participants will receive standard of care plus neck strengthening exercises during two physical therapist visits per week for six weeks.	Other: Neck Strengthening Exercises; 5 minutes of specified neck strengthening exercises two times per week for 6 weeks.
No Intervention: No intervention (control); Participants will receive standard of care plus lower limb stretching during two physical therapist visits per week for six weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Cervical Neck Flexion Force	Peak force (N) for cervical neck flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the center of forehead	Baseline testing and at 5 weeks
Time to peak force (s) for cervical neck flexion	Time to peak force (s) for cervical neck flexion captured via a handheld dynamometer. The patient will be sitting in a chair and resisting the applied force to the center of the forehead	Baseline and at 5 weeks
Peak force (N) for right cervical lateral flexion	Peak force (N) for right cervical lateral flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the right side of their head.	Baseline and at 5 weeks
Time to peak force (s) for right cervical lateral flexion	Time to peak force (s) for right cervical lateral flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the right side of their head.	Baseline and at 5 weeks
Peak force (N) for left cervical lateral flexion	Peak force (N) for left cervical lateral flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the left side of their head.	Baseline and at 5 weeks
Time to peak force (s) for left cervical lateral flexion	Time to peak force (s) for left cervical lateral flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the left side of their head.	Baseline and at 5 weeks
Peak force (N) for right cervical lateral flexion	Peak force (N) for right cervical lateral flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the front right side of their head via rotational force.	Baseline and at 5 weeks
Time to peak force (s) for right cervical lateral flexion	Time to peak force (s) for right cervical lateral flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the front right side of their head via rotational force.	Baseline and at 5 weeks
Peak force (N) for left cervical lateral flexion	Peak force (N) for left cervical lateral flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the front left side of their head via rotational force.	Baseline and at 5 weeks
Time to peak force (s) for left cervical lateral flexion	Time to peak force (s) for left cervical lateral flexion captured via a hand held dynamometer. Patient will be sitting in a chair and resist applied force to the front left side of their head via rotational force.	Baseline and at 5 weeks
Neck Cervical Repositioning Error	Measured distance (cm) between the target gaze position and the gaze returning after full neck extension. Gaze is marked via a laser pointer secured to the forehead via a headband. Patients will be seated in a chair with no arm rest with the front of the chair 20 cm away from a wall. Patients will then be instructed to find where they believe is a natural head position. Laser pointer position will be marked on the wall. Patients will then close their eyes, perform full neck extension (till the nose is pointed towards the ceiling), and attempt to find the original neck position with their eyes closed. The laser pointer position is then marked. The distance between the two dots is measured. Angular difference in head position can then be calculated using distance and angular mathematics.	Baseline and at 5 weeks
Timing error of gaze during smooth pursuits	Timing error of gaze during smooth pursuits captured via an instrumented VR headset that tracks eye movements relative to the presented image. A measure of the standard deviation of the tangential error between the participant's gaze and the target's position	Baseline and at 5 weeks
Percentile of timing error during smooth pursuits	Percentile performance for timing error of gaze during smooth pursuits captured via an instrumented VR headset that tracks eye movements relative to the presented image. Based on normative data of the equipment	Baseline and at 5 weeks
Spatial error of gaze during smooth pursuits	Spatial error of gaze during smooth pursuits captured via an instrumented VR headset that tracks eye movements relative to the presented image. A measure of the standard deviation of the radial error between the subject's gaze position and the target position.	Baseline and at 5 weeks
Percentile of Spatial Error during smooth pursuits	Percentile performance for spatial error of gaze during smooth pursuits captured via an instrumented VR headset that tracks eye movements relative to the presented image.	Baseline and at 5 weeks
Horizontal fixation accuracy during saccadic eye movement	Horizontal fixation accuracy during saccadic eye movement (rapid eye movement to a presented target) captured via an instrumented VR headset that tracks eye movements relative to the presented image. The average gaze error between the subject's fixations and the target position in the horizontal direction.	Baseline and at 5 weeks
Percentile performance for horizontal fixation accuracy during saccadic eye movement	Percentile performance for horizontal fixation accuracy during saccadic eye movement (rapid eye movement to a presented target) captured via an instrumented VR headset that tracks eye movements relative to the presented image	Baseline and at 5 weeks
Vertical fixation accuracy during vertical saccadic eye movement	Vertical fixation accuracy during vertical saccadic eye movement (rapid eye movement to a presented target) captured via an instrumented VR headset that tracks eye movements relative to the presented image.The average gaze error between the subject's fixations and the target position in the vertical direction	Baseline and at 5 weeks
Percentile performance for vertical fixation accuracy during vertical saccadic eye movement	Percentile performance for vertical fixation accuracy during vertical saccadic eye movement (rapid eye movement to a presented target) captured via an instrumented VR headset that tracks eye movements relative to the presented image	Baseline and at 5 weeks
Horizontal fixation precision during saccadic eye movement	Horizontal fixation precision during saccadic eye movement (rapid eye movement to a presented target) captured via an instrumented VR headset that tracks eye movements relative to the presented image. A measure of the standard deviation of the gaze error between the subject's fixations of both eyes in the horizontal direction.	Baseline and at 5 weeks
Percentile performance for horizontal fixation precision during saccadic eye movement	Percentile performance for horizontal fixation precision during saccadic eye movement (rapid eye movement to a presented target) captured via an instrumented VR headset that tracks eye movements relative to the presented image	Baseline and at 5 weeks
Vertical fixation precision during vertical saccadic eye movement	Vertical fixation precision during vertical saccadic eye movement (rapid eye movement to a presented target) captured via an instrumented VR headset that tracks eye movements relative to the presented image. A measure of the standard deviation of the gaze error between the subject's fixations of both eyes in the vertical direction.	Baseline and at 5 weeks
Percentile performance for vertical fixation precision during vertical saccadic eye movement	Percentile performance for vertical fixation precision during vertical saccadic eye movement (rapid eye movement to a presented target) captured via an instrumented VR headset that tracks eye movements relative to the presented image	Baseline and at 5 weeks
Center of pressure variability	Center of pressure variability during a double limb task on a firm surface captured via a force plate.	Baseline and at 5 weeks
95% Ellipse of center of pressure	95% Ellipse of center of pressure during the double limb 30-second balance task on a firm surface, determined from force plate data.	Baseline and at 5 weeks
Average lateral force variability	Average lateral force variability during double limb task on a firm surface captured via a force plate.	Baseline and at 5 weeks
Average anterior force variability	Average anterior force variability during double limb task on a firm surface captured via a force plate.	Baseline and at 5 weeks
Center of pressure variability on Foam	Center of pressure variability during double limb task on a foam surface captured via a force plate.	Baseline and at 5 weeks
95% Ellipse of center of pressure on Foam	95% Ellipse of center of pressure during double limb 30-second balance task on a foam surface determined from force plate data.	Baseline and at 5 weeks
Average lateral force variability on Foam	Average lateral force variability during double limb task on a foam surface captured via a force plate.	Baseline and at 5 weeks
Average anterior force variability on Foam	Average anterior force variability during double limb task on a foam surface captured via a force plate.	Baseline and at 5 weeks
fall self-efficacy index	The fall self-efficacy index measures the patients concern about falling during 16 social and physical activities that are part of daily living. Each of the 16 questions are scored values of 1 to 4; with one having no concern at all, 2 somewhat concerned, 3 fairly concerned, and 4 very concerned.	Baseline and at 5 weeks
dizziness handicap inventory	The dizziness handicap inventory (DHI) identifies difficulties that patients may be experiencing because of dizziness for questions about daily life. A follow-up question and the restriction is also assessed. Each of the 25 questions can be answered as Yes (4 points), Sometimes (2 points) or No (0 points). The final score is out of 100.	Baseline and at 5 weeks
Time up and Go	Time up and Go is a basic physical therapist method of testing mobility, balance, walking ability, and fall risk. The duration of time it takes to stand walk 5 meters, turn around and sit back down. Scores less than 10 seconds is considered normal and healthy, while scores exceeding 20 seconds may indicate a high risk of falls.	Baseline and at 5 weeks
Dynamic Gait index	Dynamic Gait index is a clinical assessment of an individual's dynamic balance and gait performance tested via progressive gait tasks. Each task is scored on a 4-point ordinal scale where 0 represents inability to perform the task, and 3 indicates no impairment. Scores of 19 or less is associated with increased fall risk.	Baseline and at 5 weeks
5 times sit to stand	5 times sit to stand is a basic physical therapist method of testing mobility and strength. Patient will be seated and instructed to stand up fully then sit back down as quickly as possible 5 times in a row. The duration of time it takes to complete the task is measured.	Baseline and at 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal grip strength (lbs)	Maximal grip strength (lbs) is measured via handgrip dynamometer. Best of 3 trials will be taken.	Baseline and at 5 weeks

Collaborators and Investigators

• Sponsor: Ohio University
• Investigators: Principal Investigator: Melissa Anderson, Ohio University

Publications and helpful links

General Publications

• Sturnieks DL, St George R, Lord SR. Balance disorders in the elderly. Neurophysiol Clin. 2008 Dec;38(6):467-78. doi: 10.1016/j.neucli.2008.09.001. Epub 2008 Oct 7.
• Boyd-Clark, L. C. BSc (Hons),*; Briggs, C. A. PhD,* and; Galea, M. P. PhD†. Muscle Spindle Distribution, Morphology, and Density in Longus Colli and Multifidus Muscles of the Cervical Spine. Spine 27(7):p 694-701, April 1, 2002.
• Gosselin, G., Rassoulian, H., & Brown, I. (2004). Effects of neck extensor muscles fatigue on balance. Clinical Biomechanics, 19(5), 473-479.
• Song, G. B., & Park, E. C. (2016). Effects of neck and trunk stabilization exercise on balance in older adults. The Journal of Korean Physical Therapy, 28(4), 221-226. ISSN: 1229-0475, 2287-156X
• Deshmukh, A. A., & Kanase, S. B. (2020). Effect of Activation of Deep Neck Muscles as an Adjunct to Vestibular Rehabilitation in Vertigo. Indian Journal of Public Health Research & Development, 11(2). DOI:10.37506/v11/i2/2020/ijphrd/195234

Study record dates

Study Major Dates

• Study Start (Estimated): March 16, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: physical therapy; fall risk; Community Dwelling Older Adults; neck strength
• Other Study ID Numbers: IRB-FY26-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: I will upload an Excel file with deidentified demographics and primary outcome measures for each time point of the clinical trial.
• IPD Sharing Time Frame: December 30, 2026, to December 30, 2028
• IPD Sharing Access Criteria: The information will be within an Excel document. It will include participant age, sex, height, weight, hand dominance, and primary outcome measures.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No