A Wearable "Balance Booster" - Stepping Closer to the Market

• Sponsor: RxFunction Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02115633
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 31
• Arms: 2
• Duration (Months): 14.9

Study Details

Study Description

Brief Summary

The overall goal of this project is to continue development and commercialization of a Wearable Sensory Prosthesis termed Walkasins. The device measures foot pressure through a thin sole insert, developed under National Institute on Aging (NIA) Small Business Innovation Research (SBIR) Phase I funding, and displays pressure information through a vibrotactile feedback array, placed around the lower leg, to help improve balance function. The device can replace lost foot pressure sensation in individuals with peripheral neuropathy who have balance problems.

Condition or Disease	Intervention/Treatment	Phase
Distorted; Balance; Sensation Disorders; Peripheral Neuropathy; Neuropathy	Device: Walkasins ON; Device: Walkasins OFF	N/A

Detailed Description

Our specific aims are to:

1. Revise and finalize design of Walkasins® based on accomplishments, user input, as well as reviewer criticism from our Phase 1 grant and manufacture 200 units of the device for clinical testing.

Milestone 1: 200 units manufactured and ready for clinical testing under Aim 2. This goal is accomplished.

1. Investigate effects of using Walkasins on clinical outcomes related to gait, balance function and associated fall risk in a population of patients with sensory peripheral neuropathy and balance problems.

Hypotheses 1A-B: Patients who are trained to use Walkasins programmed to display relevant balance cues will attain higher gait speed and Functional Gait Assessment when compared to a matched cohort not using Walkasins.

Milestone 2: Data collection to assess clinical utility and safety of the Walkasins on patients briefly trained to use the device has been completed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Wearable "Balance Booster" - Stepping Closer to the Market
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jul 28, 2017
• Actual Study Completion Date: Jul 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Walkasins ON; Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.; Device: Walkasins OFF; Subjects will be wearing a device that is turned off.
Experimental: 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.	Device: Walkasins ON; Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.; Device: Walkasins OFF; Subjects will be wearing a device that is turned off.

Outcome Measures

Primary Outcome Measures

1. Functional Gait Assessment (FGA) [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).

Secondary Outcome Measures

1. Four-Stage Balance Test >30s [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.

2. 10-Meter (10M) Walk Test (Measure of Gait Speed)--Number of Participants With Improvement to Normal Gait Speed [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.

3. Activities-Specific Balance Confidence Scale (ABC) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients of any age diagnosed with Peripheral Neuropathy and who experience balance problems.

• Ability to perceive the Walkasins vibration feedback, understand and physically act on the vibration feedback.

Exclusion Criteria:

• Vibration to the skin is contraindicated by physician

• Use of ankle foot orthotic that prevents attachment of Walkasins device

• Foot size smaller than Woman's 5 or larger than Men's 13

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• RxFunction Inc.
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Sara Koehler, PhD, Minneapolis VA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 5, 2016

More Information

Additional Information:

• Four-Stage Balance Test

Publications

• Beninato M, Fernandes A, Plummer LS. Minimal clinically important difference of the functional gait assessment in older adults. Phys Ther. 2014 Nov;94(11):1594-603. doi: 10.2522/ptj.20130596. Epub 2014 Jun 19.
• Hardy SE, Perera S, Roumani YF, Chandler JM, Studenski SA. Improvement in usual gait speed predicts better survival in older adults. J Am Geriatr Soc. 2007 Nov;55(11):1727-34. Epub 2007 Oct 3.
• Leddy AL, Crowner BE, Earhart GM. Functional gait assessment and balance evaluation system test: reliability, validity, sensitivity, and specificity for identifying individuals with Parkinson disease who fall. Phys Ther. 2011 Jan;91(1):102-13. doi: 10.2522/ptj.20100113. Epub 2010 Nov 11.
• Lin JH, Hsu MJ, Hsu HW, Wu HC, Hsieh CL. Psychometric comparisons of 3 functional ambulation measures for patients with stroke. Stroke. 2010 Sep;41(9):2021-5. doi: 10.1161/STROKEAHA.110.589739. Epub 2010 Jul 29.
• Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9.
• Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34.
• Wrisley DM, Kumar NA. Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther. 2010 May;90(5):761-73. doi: 10.2522/ptj.20090069. Epub 2010 Apr 1.
• Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.

• Responsible Party: RxFunction Inc.
• ClinicalTrials.gov Identifier: NCT02115633
• Other Study ID Numbers: RxF-NIA-001; 2R44AG040865-02
• First Posted: Apr 16, 2014
• Last Update Posted: Oct 30, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Sensation Disorders

Study Results

Participant Flow

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

Arm/Group Title	Walkasins On Then Off	Walkasins Off Then On
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	15	16
COMPLETED	15	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Walkasins On	Walkasins Off	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	15	16	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.6 (7.1)	71.6 (6.2)	71.6 (6.65)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	15 100%	16 100%	31 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	16 100%	31 100%
Functional Gait Assessment (FGA) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	15.0 (4.5)	15.4 (5.2)	15.2 (4.9)

Outcome Measures

1. Primary Outcome

Title	Functional Gait Assessment (FGA)
Description	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).
Time Frame	During one test session < 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Walkasins ON	Walkasins OFF
Arm/Group Description	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 wear Walkasins turned off and not receive any vibrotactile feedback.
Measure Participants	31	31
Count of Participants [Participants]	17 113.3%	7 43.8%

2. Secondary Outcome

Title	Four-Stage Balance Test >30s
Description	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.
Time Frame	The assessment requires holding each stance for 10 seconds for a total of 40 seconds to pass.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Walkasins ON	Walkasins OFF
Arm/Group Description	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.
Measure Participants	31	31
Mean (Standard Deviation) [number of seconds stances held]	27.5 (7.4)	25.6 (8.3)

3. Secondary Outcome

Title	10-Meter (10M) Walk Test (Measure of Gait Speed)--Number of Participants With Improvement to Normal Gait Speed
Description	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.
Time Frame	During one test session < 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Walkasins ON	Walkasins OFF
Arm/Group Description	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.
Measure Participants	31	31
Count of Participants [Participants]	8 53.3%	5 31.3%

4. Secondary Outcome

Title	Activities-Specific Balance Confidence Scale (ABC)
Description	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.
Time Frame	Measure was administered only at baseline during one test session <3 hours.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Walkasins ON Then OFF	Walkasins OFF
Arm/Group Description	Subjects will 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.	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 Off: Subjects will be wearing a device that is turned off.
Measure Participants	15	16
Mean (Standard Deviation) [score on a scale of 0-100]	59.6 (19.3)	64.7 (17.3)

Adverse Events

Time Frame	During a 3-hour testing period
Arm/Group Title	Walkasins ON Then OFF		Walkasins OFF Then ON
Arm/Group Description	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.		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.
All Cause Mortality
	Walkasins ON Then OFF		Walkasins OFF Then ON
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/16 (0%)
Serious Adverse Events
	Walkasins ON Then OFF		Walkasins OFF Then ON
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Walkasins ON Then OFF		Walkasins OFF Then ON
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/16 (0%)

Limitations/Caveats

Study limitations included the following: The study was not blinded. The study involved a small group consisting of males only. The study was only short-term (<3 hours).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.