Trial Outcomes & Findings for A Wearable "Balance Booster" - Stepping Closer to the Market (NCT NCT02115633)

Results Overview

The Functional Gait Assessment (FGA) is a reliable and valid measure of gait function related to postural stability and has been shown to be effective in classifying fall risk in older adults and predicting unexplained falls in community-dwelling older adults (Wrisley, Marchetti et al. 2004; Wrisley and Kumar 2010). It has also been validated in stroke survivors (Lin, Hsu et al. 2010) and patients with Parkinson's disease (Leddy, Crowner et al. 2011) and has less flooring and ceiling effect than the Dynamic Gait Index (Lin, Hsu et al. 2010). The FGA includes a 10-item scale; each item is scored from 0 to 3 (3=normal, 2=mild impairment, 1=moderate impairment, 0=severe impairment). The maximum score is 30; minimum score, 0. Higher scores represent a better outcome. To be included in the count of participants, subjects' FGA scores needed to improve more than 4 points, which is the Minimally Clinically Important Difference (MCID) (Beninato et al. 2014).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

During one test session < 3 hours

Results posted on

2018-10-30

Participant Flow

Thirty-one male community-dwelling veterans, ages 56-84, who experienced sensory peripheral neuropathy and balance problems, participated in the trial.

Participant milestones

Participant milestones
Measure	Walkasins On Then Off Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a 1-hour rest period they will be retested with Walkasins turned off. Walkasins On: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway. Walkasins Off: Subjects will be wearing a device that is turned off.	Walkasins Off Then On Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a 1-hour rest period they will be retested with Walkasins turned on. Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway. Walkasins OFF: Subjects will be wearing a device that is turned off.
Overall Study STARTED	15	16
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Walkasins On n=15 Participants Group A subjects first wore Walkasins and received real-time vibrotactile feedback that reflects real changes in center of pressure sway. Following a 1-hour rest period, they were retested with Walkasins turned off. The results for the Walkasins On state include all subjects, combining Group A, who were randomized to initially be tested with Walkasins turned on and then retested with walkasins turned off, and Group B, who were randomized to initially be tested with Walkasins turned off and then retested with Walkasins turned on.	Walkasins Off n=16 Participants Group B subjects first wore Walkasins turned off and not receive any vibrotactile feedback. Following a 1-hour rest period, they were retested with Walkasins turned on. The results for the Walkasins Off state include all subjects, combining Group A, who were randomized to initially be tested with Walkasins turned on and then retested with walkasins turned off, and Group B, who were randomized to initially be tested with Walkasins turned off and then retested with Walkasins turned on.	Total n=31 Participants Total of all reporting groups
Age, Continuous	71.6 years STANDARD_DEVIATION 7.1 • n=15 Participants	71.6 years STANDARD_DEVIATION 6.2 • n=16 Participants	71.6 years STANDARD_DEVIATION 6.65 • n=31 Participants
Sex: Female, Male Female	0 Participants n=15 Participants	0 Participants n=16 Participants	0 Participants n=31 Participants
Sex: Female, Male Male	15 Participants n=15 Participants	16 Participants n=16 Participants	31 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 participants n=15 Participants	16 participants n=16 Participants	31 participants n=31 Participants
Functional Gait Assessment (FGA) Score	15.0 units on a scale STANDARD_DEVIATION 4.5 • n=15 Participants	15.4 units on a scale STANDARD_DEVIATION 5.2 • n=16 Participants	15.2 units on a scale STANDARD_DEVIATION 4.9 • n=31 Participants

PRIMARY outcome

Timeframe: During one test session < 3 hours

The Functional Gait Assessment (FGA) is a reliable and valid measure of gait function related to postural stability and has been shown to be effective in classifying fall risk in older adults and predicting unexplained falls in community-dwelling older adults (Wrisley, Marchetti et al. 2004; Wrisley and Kumar 2010). It has also been validated in stroke survivors (Lin, Hsu et al. 2010) and patients with Parkinson's disease (Leddy, Crowner et al. 2011) and has less flooring and ceiling effect than the Dynamic Gait Index (Lin, Hsu et al. 2010). The FGA includes a 10-item scale; each item is scored from 0 to 3 (3=normal, 2=mild impairment, 1=moderate impairment, 0=severe impairment). The maximum score is 30; minimum score, 0. Higher scores represent a better outcome. To be included in the count of participants, subjects' FGA scores needed to improve more than 4 points, which is the Minimally Clinically Important Difference (MCID) (Beninato et al. 2014).

Outcome measures

Outcome measures
Measure	Walkasins ON n=31 Participants Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.	Walkasins OFF n=31 Participants Walkasins OFF: Subjects will wear Walkasins turned off and not receive any vibrotactile feedback.
Functional Gait Assessment (FGA)	17 Participants	7 Participants

SECONDARY outcome

Timeframe: The assessment requires holding each stance for 10 seconds for a total of 40 seconds to pass.

The 4-Stage Balance Test is part of the STEADI protocol recommended by the Centers for Disease Control and Prevention (CDC) to assess fall-risk in elderly individuals. It includes four gradually more challenging postures the subject performs; 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. Subjects pass if they can hold the stance for 10 seconds and then move on to the next stance. A fail during tasks 1, 2, or 3 indicates a high risk of falling, i.e., a total performance time of less than 30 seconds.

Outcome measures

Outcome measures
Measure	Walkasins ON n=31 Participants Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.	Walkasins OFF n=31 Participants Walkasins OFF: Subjects will wear Walkasins turned off and not receive any vibrotactile feedback.
Four-Stage Balance Test >30s	27.5 number of seconds stances held Standard Deviation 7.4	25.6 number of seconds stances held Standard Deviation 8.3

SECONDARY outcome

Timeframe: During one test session < 3 hours

The 10m-walk is routinely done in rehabilitation and has excellent reliability in chronic stroke patients. In addition, gait speed has been found to be an important predictor of survival in older adults (Hardy, Perera et al. 2006), further emphasizing its importance as a clinical outcomes measure. Gait speed (10-meter walk, timing only the middle 6 meters to allow for acceleration and deceleration) was assessed by instructing subjects to walk at their normal speed. A difference of 0.10m/sec is defined as the Minimally Clinical Important Difference (MCID) (Perera, Mody et al. 2006). Lower scores (# of seconds) on this measure indicate a better outcome. To be included in the count of participants, subjects' times on the 10M Walk Test needed to improve by more than 0.10m/sec, the MCID.

Outcome measures

Outcome measures
Measure	Walkasins ON n=31 Participants Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.	Walkasins OFF n=31 Participants Walkasins OFF: Subjects will wear Walkasins turned off and not receive any vibrotactile feedback.
10-Meter (10M) Walk Test (Measure of Gait Speed)--Number of Participants With Improvement to Normal Gait Speed	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Measure was administered only at baseline during one test session <3 hours.

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 ABC Scale was assessed only at baseline to document the level of balance confidence the subjects had before beginning the study intervention.

Outcome measures

Outcome measures
Measure	Walkasins ON n=15 Participants Walkasins ON: Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.	Walkasins OFF n=16 Participants Walkasins OFF: Subjects will wear Walkasins turned off and not receive any vibrotactile feedback.
Activities-Specific Balance Confidence Scale (ABC)	59.6 score on a scale of 0-100 Standard Deviation 19.3	64.7 score on a scale of 0-100 Standard Deviation 17.3

Adverse Events

Walkasins ON Then OFF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Walkasins OFF Then ON

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lars Oddsson, PhD

RxFunction, Inc.

Phone: 8572340382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place