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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.

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 Not Applicable

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.

  2. 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 Type : Interventional  (Clinical Trial)
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 2016
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : July 28, 2017

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.




Primary Outcome Measures :
  1. Functional Gait Assessment (FGA) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115633


Sponsors and Collaborators
RxFunction Inc.
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sara Koehler, PhD Minneapolis VA
  Study Documents (Full-Text)

Documents provided by RxFunction Inc.:

Additional Information:
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 Posted: April 16, 2014    Key Record Dates
Results First Posted: October 30, 2018
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Sensation Disorders
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms