Balance; Distorted, Sensation Disorders, Sensory Peripheral Neuropathy
Conditions
Keywords
Balance, Peripheral Neuropathy, Neuropathy
Brief summary
The purpose of this study is to investigate the long-term effects of Walkasins® use on clinical and subject-reported outcomes of balance and gait function, quality of life, physical activity/participation, pain, and medication use in persons with peripheral neuropathy who experience balance problems.
Detailed description
The main objectives of this single-arm study are to show a long-term (10 weeks), sustained improvement in Functional Gait Assessment (FGA) score \>4 following Walkasins use as compared to participants' initial baseline assessments and to examine a potential relationship between initial baseline assessment data and long-term outcomes. The previous finding of a short-term FGA change \>4 during Walkasins use (NCT02115633) justifies a pre-post study design to investigate the long-term effects of Walkasins use. Although the primary timeframe for the primary endpoint is 10 weeks, participants will return for follow-up visits at 26 weeks and 52 weeks of Walkasins use. The investigators also intend to extend their observations of the short-term effects of Walkasins by replicating the randomized cross-over design of a previous short-term study. (The randomized cross-over replication will occur only during the baseline visit. The long-term study consists of a single arm.) This study may help to further refine the prescription criteria for Walkasins and determine whether or not the presence of a short-term response is indicative of long-term improvements. A subset of 10 participants at the Harvard Medical School site will be enrolled in a pilot study to investigate possible structural and functional changes in cortical areas of the brain related to somatosensory connectivity using magnetic resonance imaging (MRI). Structural as well as functional MRI scans will be acquired at baseline and after 26 weeks of daily Walkasins use. An exploratory analysis of MRI data will be performed and related to functional clinical outcomes associated with Walkasins use over the same time period.
Interventions
DEVICEWalkasins
Walkasins® consist of two parts for each leg: the Haptic Module (leg unit) and the Receptor Sole (foot pad). The Haptic Module wraps around the lower leg of the user and contains electronics for reading Receptor Sole pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.
Sponsors
RxFunction Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants were randomized only during the baseline visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-90 years, male or female * Formal diagnosis of sensory peripheral neuropathy prior to participating in the study * Self-reported balance problems * Ability for transfers or ambulation on level surfaces at fixed cadence as assessed by the physical therapist during the FGA * FGA \<23, the cut-off score for high fall-risk * Ability to understand and provide informed consent * Foot size that allows Walkasins® to function appropriately * Must be able to complete all functional outcome measures without the use of an assistive device
Exclusion criteria
* Inability to perceive vibration from Walkasins leg unit * Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins * Acute thrombophlebitis including deep vein thrombosis * Untreated lymphedema * Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use * Untreated fractures in the foot and ankle * Severe peripheral vascular disease * Musculoskeletal or other neurological conditions that prohibit use of Walkasins as determined by clinician * Weighs more than 300 pounds * Plans to begin balance physical therapy (PT) during the first ten weeks of the clinical trial (Ongoing or previous balance PT is not an exclusionary criterion.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Gait Assessment | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability. (Participants scoring 23 or higher on the baseline FGA were not included in this study because their peripheral neuropathy was not yet affecting their gait/balance significantly.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test (TUG) | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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. |
| Four-Stage Balance Test | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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. |
| Activities-specific Balance Confidence (ABC) Scale | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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. |
| Vestibular Activities of Daily Living Scale (VADL) | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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). |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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. |
| 10-Meter Walk Test | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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). |
| PROMIS Pain Intensity Form 1a | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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. |
| PROMIS Ability to Participate Short Form 8a | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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). |
| PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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). |
| Falls | Baseline and 26 Weeks | 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). |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at five sites through various methods, including physician referral and recruitment posters. The first participant was enrolled on October 22, 2018, and the last participant was enrolled in April 2021.
Pre-assignment details
Sixty-nine participants met the eligibility criteria and received Walkasins, the study device, to be worn on both feet for the duration of their participation. Primary reasons for exclusion were participants' inability to feel the Walkasins stimuli, participants' need of an assistive device to complete the functional assessments, or FGA scores 23 or higher, indicating only limited gait impairments.
Participants by arm
| Arm | Count |
|---|---|
| Single-Arm Long-Term Use After the baseline visit, participants will receive Walkasins to wear over the next 52 weeks. They will return for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they will be 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. | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Long-Term Follow-up | Adverse Event | 0 | 0 | 6 |
| Long-Term Follow-up | COVID-19 Disruptions at Sites | 0 | 0 | 13 |
| Long-Term Follow-up | Death | 0 | 0 | 1 |
| Long-Term Follow-up | Device Dissatisfaction | 0 | 0 | 8 |
| Long-Term Follow-up | Withdrawal by Subject | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Single-Arm Long-Term Use |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 62 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 66 Participants |
| Region of Enrollment United States | 69 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 52 Participants |
| Weight (kg) | 89.7 Kilograms STANDARD_DEVIATION 18.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 1 / 69 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 24 / 69 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 10 / 69 |
Outcome results
Primary
Functional Gait Assessment
The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability. (Participants scoring 23 or higher on the baseline FGA were not included in this study because their peripheral neuropathy was not yet affecting their gait/balance significantly.)
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | Functional Gait Assessment | Baseline Crossover--Walkasins OFF | 17.14 score on a scale | Standard Deviation 4.5 |
| Baseline Cross-over Group A--Walkasins ON Then OFF | Functional Gait Assessment | Baseline Crossover--Walkasins ON | 17.0 score on a scale | Standard Deviation 4.5 |
| Baseline Cross-over Group A--Walkasins ON Then OFF | Functional Gait Assessment | Baseline | 14.8 score on a scale | Standard Deviation 4.1 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Functional Gait Assessment | Baseline Crossover--Walkasins OFF | 16.3 score on a scale | Standard Deviation 3.9 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Functional Gait Assessment | Baseline | 14.8 score on a scale | Standard Deviation 4.1 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Functional Gait Assessment | Baseline Crossover--Walkasins ON | 18.2 score on a scale | Standard Deviation 3.8 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Functional Gait Assessment | Baseline | 14.8 score on a scale | Standard Deviation 4.1 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Functional Gait Assessment | Week 2 | 17.9 score on a scale | Standard Deviation 4.7 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Functional Gait Assessment | Week 6 | 18.2 score on a scale | Standard Deviation 4.4 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Functional Gait Assessment | Week 10 | 19.2 score on a scale | Standard Deviation 5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Functional Gait Assessment | Week 26 | 19.1 score on a scale | Standard Deviation 4 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Functional Gait Assessment | Week 52 | 20.7 score on a scale | Standard Deviation 5.3 |
Secondary
10-Meter Walk Test
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).
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | 10-Meter Walk Test | Baseline Crossover--Walkasins OFF | 0.95 Meters/Second | Standard Deviation 0.29 |
| Baseline Cross-over Group A--Walkasins ON Then OFF | 10-Meter Walk Test | Baseline Normal Gait Speed | 0.90 Meters/Second | Standard Deviation 0.29 |
| Baseline Cross-over Group A--Walkasins ON Then OFF | 10-Meter Walk Test | Baseline Crossover--Walkasins ON | 0.92 Meters/Second | Standard Deviation 0.28 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | 10-Meter Walk Test | Baseline Crossover--Walkasins OFF | 0.90 Meters/Second | Standard Deviation 0.17 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | 10-Meter Walk Test | Baseline Normal Gait Speed | 0.85 Meters/Second | Standard Deviation 0.19 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | 10-Meter Walk Test | Baseline Crossover--Walkasins ON | 0.91 Meters/Second | Standard Deviation 0.19 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | 10-Meter Walk Test | Week 26 Normal Gait Speed | 0.97 Meters/Second | Standard Deviation 0.28 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | 10-Meter Walk Test | Baseline Normal Gait Speed | 0.88 Meters/Second | Standard Deviation 0.25 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | 10-Meter Walk Test | Week 2 Normal Gait Speed | 0.94 Meters/Second | Standard Deviation 0.28 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | 10-Meter Walk Test | Week 6 Normal Gait Speed | 0.95 Meters/Second | Standard Deviation 0.27 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | 10-Meter Walk Test | Week 10 Normal Gait Speed | 0.97 Meters/Second | Standard Deviation 0.26 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | 10-Meter Walk Test | Week 52 Normal Gait Speed | 1.02 Meters/Second | Standard Deviation 0.3 |
Secondary
Activities-specific Balance Confidence (ABC) Scale
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.
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | Activities-specific Balance Confidence (ABC) Scale | Baseline Crossover | 58.2 score on a scale | Standard Deviation 17.3 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Activities-specific Balance Confidence (ABC) Scale | Baseline Crossover | 61.2 score on a scale | Standard Deviation 16.2 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Activities-specific Balance Confidence (ABC) Scale | Baseline Crossover | 59.6 score on a scale | Standard Deviation 16.7 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Activities-specific Balance Confidence (ABC) Scale | Week 2 | 62.5 score on a scale | Standard Deviation 15.2 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Activities-specific Balance Confidence (ABC) Scale | Week 6 | 62.3 score on a scale | Standard Deviation 16.9 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Activities-specific Balance Confidence (ABC) Scale | Week 10 | 63.6 score on a scale | Standard Deviation 14.8 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Activities-specific Balance Confidence (ABC) Scale | Week 26 | 62.1 score on a scale | Standard Deviation 16.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Activities-specific Balance Confidence (ABC) Scale | Week 52 | 65.2 score on a scale | Standard Deviation 16.7 |
Secondary
Falls
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).
Time frame: Baseline and 26 Weeks
Population: 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.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Arm Long-Term Follow-up (Walkasins ON) | Falls | Pre-Study/Baseline | 53 Number of Participant Falls |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Falls | Week 26 | 39 Number of Participant Falls |
Secondary
Four-Stage Balance Test
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.
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | Four-Stage Balance Test | Baseline Crossover--Walkasins ON | 25.4 Seconds | Standard Deviation 7.5 |
| Baseline Cross-over Group A--Walkasins ON Then OFF | Four-Stage Balance Test | Baseline | 24.2 Seconds | Standard Deviation 6.9 |
| Baseline Cross-over Group A--Walkasins ON Then OFF | Four-Stage Balance Test | Baseline Crossover--Walkasins OFF | 26.0 Seconds | Standard Deviation 6.9 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Four-Stage Balance Test | Baseline Crossover--Walkasins OFF | 27.7 Seconds | Standard Deviation 6.6 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Four-Stage Balance Test | Baseline | 26.5 Seconds | Standard Deviation 8 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Four-Stage Balance Test | Baseline Crossover--Walkasins ON | 26.6 Seconds | Standard Deviation 6.4 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Four-Stage Balance Test | Baseline | 25.3 Seconds | Standard Deviation 7.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Four-Stage Balance Test | Week 2 | 27.1 Seconds | Standard Deviation 8 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Four-Stage Balance Test | Week 6 | 27.4 Seconds | Standard Deviation 7.4 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Four-Stage Balance Test | Week 10 | 27.3 Seconds | Standard Deviation 6.9 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Four-Stage Balance Test | Week 26 | 28.4 Seconds | Standard Deviation 5.6 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Four-Stage Balance Test | Week 52 | 31.1 Seconds | Standard Deviation 6.8 |
Secondary
Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | Patient Health Questionnaire-9 (PHQ-9) | Baseline | 5.19 score on a scale | Standard Deviation 4.63 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Patient Health Questionnaire-9 (PHQ-9) | Baseline | 4.30 score on a scale | Standard Deviation 3.53 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient Health Questionnaire-9 (PHQ-9) | Baseline | 4.77 score on a scale | Standard Deviation 4.13 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient Health Questionnaire-9 (PHQ-9) | Week 2 | 3.97 score on a scale | Standard Deviation 3.96 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient Health Questionnaire-9 (PHQ-9) | Week 6 | 4.12 score on a scale | Standard Deviation 4.16 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient Health Questionnaire-9 (PHQ-9) | Week 10 | 4.18 score on a scale | Standard Deviation 4.62 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient Health Questionnaire-9 (PHQ-9) | Week 26 | 4.19 score on a scale | Standard Deviation 4.03 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient Health Questionnaire-9 (PHQ-9) | Week 52 | 4.83 score on a scale | Standard Deviation 4.95 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b
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.
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Baseline | 52.6 T-score | Standard Deviation 8.3 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Baseline | 50.1 T-score | Standard Deviation 8.7 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Baseline | 51.4 T-score | Standard Deviation 8.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Week 2 | 51.7 T-score | Standard Deviation 7.8 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Week 6 | 51.1 T-score | Standard Deviation 8.9 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Week 10 | 52.2 T-score | Standard Deviation 8.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Week 26 | 51.2 T-score | Standard Deviation 8.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b | Week 52 | 52.8 T-score | Standard Deviation 9.1 |
Secondary
PROMIS Ability to Participate Short Form 8a
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).
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | PROMIS Ability to Participate Short Form 8a | Baseline | 48.8 score on a scale | Standard Deviation 7.7 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | PROMIS Ability to Participate Short Form 8a | Baseline | 50.7 score on a scale | Standard Deviation 8.7 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Ability to Participate Short Form 8a | Baseline | 49.7 score on a scale | Standard Deviation 8.2 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Ability to Participate Short Form 8a | Week 2 | 51.1 score on a scale | Standard Deviation 7.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Ability to Participate Short Form 8a | Week 6 | 50.9 score on a scale | Standard Deviation 7.3 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Ability to Participate Short Form 8a | Week 10 | 51.1 score on a scale | Standard Deviation 7.9 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Ability to Participate Short Form 8a | Week 26 | 52.0 score on a scale | Standard Deviation 8.1 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Ability to Participate Short Form 8a | Week 52 | 48.7 score on a scale | Standard Deviation 7.9 |
Secondary
PROMIS Pain Intensity Form 1a
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.
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | PROMIS Pain Intensity Form 1a | Baseline | 3.2 score on a scale | Standard Deviation 2.6 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | PROMIS Pain Intensity Form 1a | Baseline | 2.4 score on a scale | Standard Deviation 2 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Pain Intensity Form 1a | Week 2 | 2.6 score on a scale | Standard Deviation 2.1 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Pain Intensity Form 1a | Week 6 | 2.8 score on a scale | Standard Deviation 2.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Pain Intensity Form 1a | Week 10 | 2.7 score on a scale | Standard Deviation 2.4 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Pain Intensity Form 1a | Week 26 | 2.7 score on a scale | Standard Deviation 2.1 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Pain Intensity Form 1a | Week 52 | 3.2 score on a scale | Standard Deviation 2.9 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Pain Intensity Form 1a | Baseline | 2.8 score on a scale | Standard Deviation 2.3 |
Secondary
PROMIS Satisfaction With Participation in Social Roles Short Form 8a
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).
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Baseline | 47.7 score on a scale | Standard Deviation 6.3 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Baseline | 49.9 score on a scale | Standard Deviation 8.1 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Baseline | 48.7 score on a scale | Standard Deviation 7.3 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Week 2 | 49.2 score on a scale | Standard Deviation 7.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Week 6 | 50.1 score on a scale | Standard Deviation 7.9 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Week 10 | 50.4 score on a scale | Standard Deviation 8.4 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Week 26 | 51.0 score on a scale | Standard Deviation 8.3 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | PROMIS Satisfaction With Participation in Social Roles Short Form 8a | Week 52 | 49.4 score on a scale | Standard Deviation 8.5 |
Secondary
Timed Up and Go Test (TUG)
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.
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | Timed Up and Go Test (TUG) | Baseline Crossover--Walkasins ON | 13.7 Seconds | Standard Deviation 5.2 |
| Baseline Cross-over Group A--Walkasins ON Then OFF | Timed Up and Go Test (TUG) | Baseline | 13.9 Seconds | Standard Deviation 6.2 |
| Baseline Cross-over Group A--Walkasins ON Then OFF | Timed Up and Go Test (TUG) | Baseline Crossover--Walkasins OFF | 13.2 Seconds | Standard Deviation 5.8 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Timed Up and Go Test (TUG) | Baseline Crossover--Walkasins OFF | 12.7 Seconds | Standard Deviation 3.7 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Timed Up and Go Test (TUG) | Baseline | 13.5 Seconds | Standard Deviation 4.5 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Timed Up and Go Test (TUG) | Baseline Crossover--Walkasins ON | 12.8 Seconds | Standard Deviation 3.9 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Timed Up and Go Test (TUG) | Baseline | 13.7 Seconds | Standard Deviation 5.5 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Timed Up and Go Test (TUG) | Week 2 | 12.8 Seconds | Standard Deviation 4.2 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Timed Up and Go Test (TUG) | Week 6 | 12.4 Seconds | Standard Deviation 4.2 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Timed Up and Go Test (TUG) | Week 10 | 12.1 Seconds | Standard Deviation 3.6 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Timed Up and Go Test (TUG) | Week 26 | 12.3 Seconds | Standard Deviation 3.4 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Timed Up and Go Test (TUG) | Week 52 | 12.2 Seconds | Standard Deviation 3.7 |
Secondary
Vestibular Activities of Daily Living Scale (VADL)
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).
Time frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cross-over Group A--Walkasins ON Then OFF | Vestibular Activities of Daily Living Scale (VADL) | Baseline | 3.97 score on a scale | Standard Deviation 1.13 |
| Baseline Cross-over Group B--Walkasins OFF Then ON | Vestibular Activities of Daily Living Scale (VADL) | Baseline | 3.82 score on a scale | Standard Deviation 1.15 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Vestibular Activities of Daily Living Scale (VADL) | Baseline | 3.89 score on a scale | Standard Deviation 1.14 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Vestibular Activities of Daily Living Scale (VADL) | Week 2 | 3.49 score on a scale | Standard Deviation 1.1 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Vestibular Activities of Daily Living Scale (VADL) | Week 6 | 3.66 score on a scale | Standard Deviation 1.09 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Vestibular Activities of Daily Living Scale (VADL) | Week 10 | 3.78 score on a scale | Standard Deviation 1.03 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Vestibular Activities of Daily Living Scale (VADL) | Week 26 | 3.66 score on a scale | Standard Deviation 1.22 |
| Single-Arm Long-Term Follow-up (Walkasins ON) | Vestibular Activities of Daily Living Scale (VADL) | Week 52 | 3.62 score on a scale | Standard Deviation 1.12 |