The Timed Up and Go Test is part of the Centers for Disease Control (CDC)-recommended STEADI test protocol for balance function. From a seated position in a standard armchair, the participant is asked to stand up from the chair, walk to a line on the floor 10 feet away at normal pace, turn, walk back to the chair at normal pace, and sit down again. The tester records the time taken from the command "Go" until the subject sits down again. Lower times indicate better/faster performance.

The 4-Stage Balance Test is part of the Centers for Disease Control's recommended test protocol for balance function. It includes four gradually more challenging postures the subject is exposed to: (1) Stand with feet side by side. (2) Stand with feet in semi-tandem stance. (3) Stand with feet in tandem stance. (4) Stand on one leg. Participants pass each level if they can hold the stance for 10 seconds and then move on to the next stance. If they cannot hold the stance, the test ends. Higher times indicate better balance than lower times.

Powell and Myers (1995) developed the Activities-specific Balance Confidence (ABC) Scale to detect levels of balance confidence in elderly persons. The ABC scale is a one-page questionnaire that asks questions about balance confidence when performing 16 different tasks. The items are rated on a scale of 0 to 100; a score of 0 indicates no confidence and a score of 100 indicates complete confidence when performing the task. The overall score is calculated by adding the individual items then dividing by the total number of items (16). The higher the score, the greater the person's balance confidence; thus, higher scores indicate that subjects are more confident of their balance.

The Vestibular Activities of Daily Living Scale (VADL) is a self-reported questionnaire that was developed to assess self-perceived disability in individuals with vestibular impairment. It evaluates the effects of vertigo and balance disorders on independence in 28 activities of daily living. Participants selected a number ranging from 1 = "Independent" to 10 = "Too Difficult, No Longer Perform." The scores on the 28 activities were averaged. The higher the score (up to 10), the greater is the person's self-perceived disability (i.e., the person feels less independence in activities of daily living). Lower averages of the 28 items indicate greater independence in activities of daily living (e.g., a healthy adult's VADL score most likely would be between 1.0 and 2.0).

The PHQ-9 is a nine-question tool for assessing depression and emotional well-being. Participants rate nine areas on a 0 to 3 scale in response to the question, "Over the last 2 weeks, how often have you been bothered by any of the following problems?" The rating scale is as follows: 0 = "Not at All," 1 = "Several Days," 2 = "More Than Half the Days," and 3 = "Nearly Every Day." A PHQ-9 total score of 0-4 points indicates "normal" or minimal depression. Scores between 5-9 points indicate mild depression; 10-14 points, moderate depression; 15-19 points, moderately severe depression; and 20 or more points, severe depression. (The minimum score on the PHQ-9 is 0; the maximum score is 27.) In short, lower scores indicate less depression.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b measures the self-reported consequences of pain on relevant aspects of a person's life over the past 7 days and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). Higher scores (i.e., those greater than 50, the mean) indicate that the participants perceive their pain as interfering in their daily lives more than average; lower scores (i.e., those less than 50, the mean) indicate that the participants perceive their pain as interfering less than average in their daily lives, which would be considered a better outcome.

The PROMIS Pain Intensity Form 1a instrument asks participants to rate the intensity of their pain on average over the previous 7 days. It is universal rather than disease specific. The higher the score on a scale of 0 ("no pain") to 10 ("worst pain imaginable), the more intense is the person's perception of pain; lower scores indicate less intense perception of pain, a better outcome.

The PROMIS Ability to Participate in Social Roles and Activities assesses the participants' perceived ability to perform their usual social roles and activities. PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). A higher score (i.e., greater than 50, the mean) indicates participants perceive they have a better ability to participate in their roles and activities (i.e., a better outcome).

The PROMIS Satisfaction with Social Roles and Activities items assess satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities"). PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). A higher score (i.e., those greater than 50, the mean) indicates the respondents' greater satisfaction in regard to their ability to participate in their roles and activities (i.e., a better outcome).

Subjects were asked about the number of times they have fallen in the past 6 and 12 months and whether they incurred an injury from falling. (For this study, the researchers used the World Health Organization's definition of a fall: "an event which results in a person coming to rest inadvertently on the ground or floor or other lower level.") These data were compared to falls during their participation in the trial as tracked with a calendar and reported as adverse events. Falls data were monitored as overall number of falls and fallers pre-and post-study participation as well as the number of falls/1000 patient days. A lower number indicates fewer falls over 26 weeks (6 months).

Gait speed (10-meter walk, timing the middle 6 meters) is assessed under two conditions: Participants are instructed (1) to walk at normal speed and (2) to walk as fast as they can. Higher numbers indicate faster speeds (i.e., more meters per second).

Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

The Timed Up and Go Test is part of the Centers for Disease Control (CDC)-recommended STEADI test protocol for balance function. From a seated position in a standard armchair, the participant is asked to stand up from the chair, walk to a line on the floor 10 feet away at normal pace, turn, walk back to the chair at normal pace, and sit down again. The tester records the time taken from the command "Go" until the subject sits down again. Lower times indicate better/faster performance.

Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

The 4-Stage Balance Test is part of the Centers for Disease Control's recommended test protocol for balance function. It includes four gradually more challenging postures the subject is exposed to: (1) Stand with feet side by side. (2) Stand with feet in semi-tandem stance. (3) Stand with feet in tandem stance. (4) Stand on one leg. Participants pass each level if they can hold the stance for 10 seconds and then move on to the next stance. If they cannot hold the stance, the test ends. Higher times indicate better balance than lower times.

Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

Powell and Myers (1995) developed the Activities-specific Balance Confidence (ABC) Scale to detect levels of balance confidence in elderly persons. The ABC scale is a one-page questionnaire that asks questions about balance confidence when performing 16 different tasks. The items are rated on a scale of 0 to 100; a score of 0 indicates no confidence and a score of 100 indicates complete confidence when performing the task. The overall score is calculated by adding the individual items then dividing by the total number of items (16). The higher the score, the greater the person's balance confidence; thus, higher scores indicate that subjects are more confident of their balance.

IBecause of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

The Vestibular Activities of Daily Living Scale (VADL) is a self-reported questionnaire that was developed to assess self-perceived disability in individuals with vestibular impairment. It evaluates the effects of vertigo and balance disorders on independence in 28 activities of daily living. Participants selected a number ranging from 1 = "Independent" to 10 = "Too Difficult, No Longer Perform." The scores on the 28 activities were averaged. The higher the score (up to 10), the greater is the person's self-perceived disability (i.e., the person feels less independence in activities of daily living). Lower averages of the 28 items indicate greater independence in activities of daily living (e.g., a healthy adult's VADL score most likely would be between 1.0 and 2.0).

Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

The PHQ-9 is a nine-question tool for assessing depression and emotional well-being. Participants rate nine areas on a 0 to 3 scale in response to the question, "Over the last 2 weeks, how often have you been bothered by any of the following problems?" The rating scale is as follows: 0 = "Not at All," 1 = "Several Days," 2 = "More Than Half the Days," and 3 = "Nearly Every Day." A PHQ-9 total score of 0-4 points indicates "normal" or minimal depression. Scores between 5-9 points indicate mild depression; 10-14 points, moderate depression; 15-19 points, moderately severe depression; and 20 or more points, severe depression. (The minimum score on the PHQ-9 is 0; the maximum score is 27.) In short, lower scores indicate less depression.

Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b measures the self-reported consequences of pain on relevant aspects of a person's life over the past 7 days and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). Higher scores (i.e., those greater than 50, the mean) indicate that the participants perceive their pain as interfering in their daily lives more than average; lower scores (i.e., those less than 50, the mean) indicate that the participants perceive their pain as interfering less than average in their daily lives, which would be considered a better outcome.

Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

The PROMIS Pain Intensity Form 1a instrument asks participants to rate the intensity of their pain on average over the previous 7 days. It is universal rather than disease specific. The higher the score on a scale of 0 ("no pain") to 10 ("worst pain imaginable), the more intense is the person's perception of pain; lower scores indicate less intense perception of pain, a better outcome.

IBecause of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

The PROMIS Ability to Participate in Social Roles and Activities assesses the participants' perceived ability to perform their usual social roles and activities. PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). A higher score (i.e., greater than 50, the mean) indicates participants perceive they have a better ability to participate in their roles and activities (i.e., a better outcome).

Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

The PROMIS Satisfaction with Social Roles and Activities items assess satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities"). PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). A higher score (i.e., those greater than 50, the mean) indicates the respondents' greater satisfaction in regard to their ability to participate in their roles and activities (i.e., a better outcome).

Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)

Subjects were asked about the number of times they have fallen in the past 6 and 12 months and whether they incurred an injury from falling. (For this study, the researchers used the World Health Organization's definition of a fall: "an event which results in a person coming to rest inadvertently on the ground or floor or other lower level.") These data were compared to falls during their participation in the trial as tracked with a calendar and reported as adverse events. Falls data were monitored as overall number of falls and fallers pre-and post-study participation as well as the number of falls/1000 patient days. A lower number indicates fewer falls over 26 weeks (6 months).

Data on falls were collected and analyzed for 44 participants who completed at least 26 weeks of the study. (At baseline subjects reported the number of falls they had experienced in the six months prior to their participation in the trial.)

Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.

After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.

During the baseline visit, participants were randomized to two groups that applied to the first visit only. After the baseline visit, all the participants received Walkasins to wear over the next 52 weeks (single arm). They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, device usage, and device functioning.

Hospitalizations were for pneumonia/respiratory problems; they were unrelated to device use.

Hospitalizations were for hip fractures; they were unrelated to device use.

Hospitalization was for critical anemia; it was unrelated to device use.

Hospitalization was for severe hypotension; it was unrelated to device use.

Hospitalization was for low magnesium; it was unrelated to device use.

Hospitalization was for mental health; it was unrelated to device use.

Hospitalization was for a surgical procedure; it was unrelated to device use.

Skin irritation includes blisters, cracked skin, rashes, etc. on participants' feet or lower legs.