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AgingNCT07503899

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

A study testing Neck Strengthening Exercises in people with Aging and Fall Injury Prevention, run by Ohio University at 1 site in United States.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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 more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aging, Fall Injury Prevention, At Fall Risk
What is being tested?
Neck Strengthening Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
16 Mar 2026to 1 Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abigail Aultz contact

2088412279

aa425625@ohio.edu

United States1 site
  • Ohio University

    Athens, Ohio, 45701

    Abigail Aultz, 2088412279, aa425625@ohio.edu

    Melissa Anderson

Other trials in United States

About this study

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.

Being tested
Neck Strengthening Exercises
Keywords
physical therapy, fall risk, neck strength, Community Dwelling Older Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neck Strengthening ExercisesOther

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

Study groups in NCT07503899
Study groupRoleWhat they receive
Neck Strengthening InterventionActive comparatorParticipants will receive standard of care plus neck strengthening exercises during two physical therapist visits per week for six weeks.
Receives: Other: Neck Strengthening Exercises
No intervention (control)No interventionParticipants will receive standard of care plus lower limb stretching during two physical therapist visits per week for six weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and at 5 weeks

Secondary outcomes (1)
  1. Maximal grip strength (lbs)

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

    Measured: Baseline and at 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2026
  2. Study start16 Mar 2026 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two randomized groups: the interventional neck strengthening group and the control lower limb stretching group.
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07503899
Sponsor's protocol ID
IRB-FY26-126
Status last verified
Feb 2026
First submitted
13 Mar 2026
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: I will upload an Excel file with deidentified demographics and primary outcome measures for each time point of the clinical trial.

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

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