ClinicalTrials.gg
Not yet recruitingNCT07503899Updated Mar 31, 2026

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

An interventional study of Neck Strengthening Exercises in Aging, Fall Injury Prevention and At Fall Risk, sponsored by Ohio University. Not yet recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Ohio University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Aging
  • Fall Injury Prevention
  • At Fall Risk

Keywords

  • physical therapy
  • fall risk
  • neck strength
  • Community Dwelling Older Adults
03

In context

Lead sponsor

Ohio University is the lead sponsor of 65 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • legally blind
  • taking meclizine
  • unable to follow simple motor commands
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherNeck Strengthening Exercises

    5 minutes of specified neck strengthening exercises two times per week for 6 weeks.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline testing and at 5 weeks

  2. 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

    Time frame: Baseline and at 5 weeks

  3. 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.

    Time frame: Baseline and at 5 weeks

  4. 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.

    Time frame: Baseline and at 5 weeks

  5. 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.

    Time frame: Baseline and at 5 weeks

  6. 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.

    Time frame: Baseline and at 5 weeks

  7. 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.

    Time frame: Baseline and at 5 weeks

  8. 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.

    Time frame: Baseline and at 5 weeks

  9. 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.

    Time frame: Baseline and at 5 weeks

  10. 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.

    Time frame: Baseline and at 5 weeks

  11. 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.

    Time frame: Baseline and at 5 weeks

  12. 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

    Time frame: Baseline and at 5 weeks

  13. 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

    Time frame: Baseline and at 5 weeks

  14. 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.

    Time frame: Baseline and at 5 weeks

  15. 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.

    Time frame: Baseline and at 5 weeks

  16. 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.

    Time frame: Baseline and at 5 weeks

  17. 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

    Time frame: Baseline and at 5 weeks

  18. 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

    Time frame: Baseline and at 5 weeks

  19. 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

    Time frame: Baseline and at 5 weeks

  20. 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.

    Time frame: Baseline and at 5 weeks

  21. 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

    Time frame: Baseline and at 5 weeks

  22. 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.

    Time frame: Baseline and at 5 weeks

  23. 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

    Time frame: Baseline and at 5 weeks

  24. Center of pressure variability

    Center of pressure variability during a double limb task on a firm surface captured via a force plate.

    Time frame: Baseline and at 5 weeks

  25. 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.

    Time frame: Baseline and at 5 weeks

  26. Average lateral force variability

    Average lateral force variability during double limb task on a firm surface captured via a force plate.

    Time frame: Baseline and at 5 weeks

  27. Average anterior force variability

    Average anterior force variability during double limb task on a firm surface captured via a force plate.

    Time frame: Baseline and at 5 weeks

  28. Center of pressure variability on Foam

    Center of pressure variability during double limb task on a foam surface captured via a force plate.

    Time frame: Baseline and at 5 weeks

  29. 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.

    Time frame: Baseline and at 5 weeks

  30. Average lateral force variability on Foam

    Average lateral force variability during double limb task on a foam surface captured via a force plate.

    Time frame: Baseline and at 5 weeks

  31. Average anterior force variability on Foam

    Average anterior force variability during double limb task on a foam surface captured via a force plate.

    Time frame: Baseline and at 5 weeks

  32. 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.

    Time frame: Baseline and at 5 weeks

  33. 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.

    Time frame: Baseline and at 5 weeks

  34. 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.

    Time frame: Baseline and at 5 weeks

  35. 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.

    Time frame: Baseline and at 5 weeks

  36. 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.

    Time frame: Baseline and at 5 weeks

Secondary outcomes

  1. Maximal grip strength (lbs)

    Maximal grip strength (lbs) is measured via handgrip dynamometer. Best of 3 trials will be taken.

    Time frame: Baseline and at 5 weeks

07

Study locations

1 site
08

References and documents

Publications

  • Boyd-Clark LC, Briggs CA, Galea MP. Muscle spindle distribution, morphology, and density in longus colli and multifidus muscles of the cervical spine. Spine (Phila Pa 1976). 2002 Apr 1;27(7):694-701. doi: 10.1097/00007632-200204010-00005. PubMed 11923661 ↗
  • Gosselin G, Rassoulian H, Brown I. Effects of neck extensor muscles fatigue on balance. Clin Biomech (Bristol). 2004 Jun;19(5):473-9. doi: 10.1016/j.clinbiomech.2004.02.001. PubMed 15182982 ↗
  • 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
  • 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. PubMed 19026966 ↗

Individual participant data

Plan to share: Yes — I will upload an Excel file with deidentified demographics and primary outcome measures for each time point of the clinical trial.

Time frame: December 30, 2026, to December 30, 2028

Access criteria: The information will be within an Excel document. It will include participant age, sex, height, weight, hand dominance, and primary outcome measures.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07503899
Lead sponsor
Ohio University
Responsible party
Sponsor
First posted
Mar 31, 2026
Start date
Mar 16, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Mar 31, 2026

Study contacts

Abigail Aultz
Contact
aa425625@ohio.edu
2088412279
Melissa Anderson
principal investigator · Ohio University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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