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.
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.
United States1 site
Ohio University
Athens, Ohio, 45701
Abigail Aultz, 2088412279, aa425625@ohio.edu
Melissa Anderson
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.
- Conditions
- Aging, Fall Injury Prevention, At 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neck Strengthening Exercises |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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.
- First posted31 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Anderson, Principal investigator, Ohio University
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 11923661Gosselin 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 15182982Song, 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