Ohio University
Athens, Ohio, 45701, United States
NCT Number: NCT07503899
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
Athens, Ohio, 45701, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 minutes of specified neck strengthening exercises two times per week for 6 weeks.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.
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.
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
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
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
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.
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
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.
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
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.
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.
Time frame: Baseline and at 5 weeks
Average lateral force variability during double limb task on a firm surface captured via a force plate.
Time frame: Baseline and at 5 weeks
Average anterior force variability during double limb task on a firm surface captured via a force plate.
Time frame: Baseline and at 5 weeks
Center of pressure variability during double limb task on a foam surface captured via a force plate.
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.
Time frame: Baseline and at 5 weeks
Average lateral force variability during double limb task on a foam surface captured via a force plate.
Time frame: Baseline and at 5 weeks
Average anterior force variability during double limb task on a foam surface captured via a force plate.
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.
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.
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.
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.
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.
Time frame: Baseline and at 5 weeks
Maximal grip strength (lbs) is measured via handgrip dynamometer. Best of 3 trials will be taken.
Contact information is provided by the study sponsor or research team.
Ohio University
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