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

NCT07503899 | Not Yet Recruiting

• 1 other identifier: IRB-FY26-126
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Fall Injury Prevention; At Fall Risk

Keywords

physical therapy; fall risk; neck strength; Community Dwelling Older Adults

Outcome Measures

Primary Outcomes (36)

• 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.

  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

Secondary Outcomes (1)

• Maximal grip strength (lbs)

  Baseline and at 5 weeks

Study Arms (2)

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.

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.

Interventions

Neck Strengthening Exercises OTHER

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

Neck Strengthening Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (5)

• Boyd-Clark, L. C. BSc (Hons),*; Briggs, C. A. PhD,* and; Galea, M. P. PhD†. Muscle Spindle Distribution, Morphology, and Density in Longus Colli and Multifidus Muscles of the Cervical Spine. Spine 27(7):p 694-701, April 1, 2002.

  BACKGROUND

• Gosselin, G., Rassoulian, H., & Brown, I. (2004). Effects of neck extensor muscles fatigue on balance. Clinical Biomechanics, 19(5), 473-479.

  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

  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.

  PMID: 19026966 BACKGROUND

Study Officials

• Melissa Anderson

  Ohio University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Aultz

CONTACT

2088412279; aa425625@ohio.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two randomized groups: the interventional neck strengthening group and the control lower limb stretching group.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 31, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)