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Trial record 2 of 2 for:    walkasins

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

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ClinicalTrials.gov Identifier: NCT02115633
Recruitment Status : Completed
First Posted : April 16, 2014
Results First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
RxFunction Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Distorted; Balance
Sensation Disorders
Peripheral Neuropathy
Neuropathy
Interventions Device: Walkasins ON
Device: Walkasins OFF
Enrollment 31
Recruitment Details Thirty-one male community-dwelling veterans, ages 56-84, who experienced sensory peripheral neuropathy and balance problems, participated in the trial.
Pre-assignment Details  
Arm/Group Title Walkasins On Then Off Walkasins Off Then On
Hide 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
Arm/Group Title Walkasins On Walkasins Off Total
Hide 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 Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
71.6  (7.1) 71.6  (6.2) 71.6  (6.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
15
 100.0%
16
 100.0%
31
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 16 participants 31 participants
15 16 31
Functional Gait Assessment (FGA) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 16 participants 31 participants
15.0  (4.5) 15.4  (5.2) 15.2  (4.9)
[1]
Measure Description: The 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. The FGA includes a 10-item scale where each item is scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). The maximum score is 30; the minimum score is 0. Higher scores represent a better outcome. An increase >4 is considered the MCID for community-dwelling elderly individuals (Beninato et al. 2014).
1.Primary Outcome
Title Functional Gait Assessment (FGA)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Walkasins ON Walkasins OFF
Hide 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.
Overall Number of Participants Analyzed 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
17
  54.8%
7
  22.6%
2.Secondary Outcome
Title Four-Stage Balance Test >30s
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Walkasins ON Walkasins OFF
Hide 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.
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Walkasins ON Walkasins OFF
Hide 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.
Overall Number of Participants Analyzed 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
8
  25.8%
5
  16.1%
4.Secondary Outcome
Title Activities-Specific Balance Confidence Scale (ABC)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Walkasins ON Then OFF Walkasins OFF
Hide 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.

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale of 0-100
59.6  (19.3) 64.7  (17.3)
Time Frame During a 3-hour testing period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Walkasins ON Then OFF Walkasins OFF Then ON
Hide 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 (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Walkasins ON Then OFF Walkasins OFF Then ON
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Walkasins ON Then OFF Walkasins OFF Then ON
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 

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).
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.
Results Point of Contact
Name/Title: Lars Oddsson, PhD
Organization: RxFunction, Inc.
Phone: 8572340382
Publications:
Responsible Party: RxFunction Inc.
ClinicalTrials.gov Identifier: NCT02115633     History of Changes
Other Study ID Numbers: RxF-NIA-001
2R44AG040865-02 ( U.S. NIH Grant/Contract )
First Submitted: April 14, 2014
First Posted: April 16, 2014
Results First Submitted: July 9, 2018
Results First Posted: October 30, 2018
Last Update Posted: October 30, 2018