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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neck Strengthening Intervention | Active Comparator | Participants will receive standard of care plus neck strengthening exercises during two physical therapist visits per week for six weeks. |
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| No intervention (control) | No Intervention | Participants will receive standard of care plus lower limb stretching during two physical therapist visits per week for six weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neck Strengthening Exercises | Other | 5 minutes of specified neck strengthening exercises two times per week for 6 weeks. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abigail Aultz | Contact | 2088412279 | aa425625@ohio.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Anderson | Ohio University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio University | Athens | Ohio | 45701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11923661 | Background | 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. | |
| 15182982 | Background | 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. |
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I will upload an Excel file with deidentified demographics and primary outcome measures for each time point of the clinical trial.
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December 30, 2026, to December 30, 2028
The information will be within an Excel document. It will include participant age, sex, height, weight, hand dominance, and primary outcome measures.
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Two randomized groups: the interventional neck strengthening group and the control lower limb stretching group.
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| 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 |
| Background | 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 |
| Background | 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 |
| 19026966 | Background | 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. |