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NCT Number: NCT07503899

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

Location contact

Abigail Aultz

CONTACT

[email protected]

2088412279

Melissa Anderson

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neck Strengthening Exercises

Other

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

Primary outcomes

  1. Peak Cervical Neck Flexion Force

    Time frame: Baseline testing and at 5 weeks

    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

  2. Time to peak force (s) for cervical neck flexion

    Time frame: Baseline and at 5 weeks

    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

  3. Peak force (N) for right cervical lateral flexion

    Time frame: Baseline and at 5 weeks

    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.

  4. Time to peak force (s) for right cervical lateral flexion

    Time frame: Baseline and at 5 weeks

    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.

  5. Peak force (N) for left cervical lateral flexion

    Time frame: Baseline and at 5 weeks

    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.

  6. Time to peak force (s) for left cervical lateral flexion

    Time frame: Baseline and at 5 weeks

    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.

  7. Peak force (N) for right cervical lateral flexion

    Time frame: Baseline and at 5 weeks

    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.

  8. Time to peak force (s) for right cervical lateral flexion

    Time frame: Baseline and at 5 weeks

    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.

  9. Peak force (N) for left cervical lateral flexion

    Time frame: Baseline and at 5 weeks

    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.

  10. Time to peak force (s) for left cervical lateral flexion

    Time frame: Baseline and at 5 weeks

    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.

  11. Neck Cervical Repositioning Error

    Time frame: Baseline and at 5 weeks

    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.

  12. Timing error of gaze during smooth pursuits

    Time frame: Baseline and at 5 weeks

    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

  13. Percentile of timing error during smooth pursuits

    Time frame: Baseline and at 5 weeks

    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

  14. Spatial error of gaze during smooth pursuits

    Time frame: Baseline and at 5 weeks

    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.

  15. Percentile of Spatial Error during smooth pursuits

    Time frame: Baseline and at 5 weeks

    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.

  16. Horizontal fixation accuracy during saccadic eye movement

    Time frame: Baseline and at 5 weeks

    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.

  17. Percentile performance for horizontal fixation accuracy during saccadic eye movement

    Time frame: Baseline and at 5 weeks

    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

  18. Vertical fixation accuracy during vertical saccadic eye movement

    Time frame: Baseline and at 5 weeks

    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

  19. Percentile performance for vertical fixation accuracy during vertical saccadic eye movement

    Time frame: Baseline and at 5 weeks

    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

  20. Horizontal fixation precision during saccadic eye movement

    Time frame: Baseline and at 5 weeks

    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.

  21. Percentile performance for horizontal fixation precision during saccadic eye movement

    Time frame: Baseline and at 5 weeks

    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

  22. Vertical fixation precision during vertical saccadic eye movement

    Time frame: Baseline and at 5 weeks

    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.

  23. Percentile performance for vertical fixation precision during vertical saccadic eye movement

    Time frame: Baseline and at 5 weeks

    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

  24. Center of pressure variability

    Time frame: Baseline and at 5 weeks

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

  25. 95% Ellipse of center of pressure

    Time frame: Baseline and at 5 weeks

    95% Ellipse of center of pressure during the double limb 30-second balance task on a firm surface, determined from force plate data.

  26. Average lateral force variability

    Time frame: Baseline and at 5 weeks

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

  27. Average anterior force variability

    Time frame: Baseline and at 5 weeks

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

  28. Center of pressure variability on Foam

    Time frame: Baseline and at 5 weeks

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

  29. 95% Ellipse of center of pressure on Foam

    Time frame: Baseline and at 5 weeks

    95% Ellipse of center of pressure during double limb 30-second balance task on a foam surface determined from force plate data.

  30. Average lateral force variability on Foam

    Time frame: Baseline and at 5 weeks

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

  31. Average anterior force variability on Foam

    Time frame: Baseline and at 5 weeks

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

  32. fall self-efficacy index

    Time frame: Baseline and at 5 weeks

    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.

  33. dizziness handicap inventory

    Time frame: Baseline and at 5 weeks

    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.

  34. Time up and Go

    Time frame: Baseline and at 5 weeks

    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.

  35. Dynamic Gait index

    Time frame: Baseline and at 5 weeks

    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.

  36. 5 times sit to stand

    Time frame: Baseline and at 5 weeks

    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.

Secondary outcomes

  1. Maximal grip strength (lbs)

    Time frame: Baseline and at 5 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Aultz

CONTACT

[email protected]

2088412279

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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