A Wearable "Balance Booster" - Stepping Closer to the Market
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Functional Gait Assessment (FGA)
研究概览
简要总结
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.
详细描述
Our specific aims are to:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Walkasins ON (Device)
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.
干预措施: Walkasins OFF (Device)
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.
干预措施: Walkasins ON (Device)
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.
干预措施: Walkasins OFF (Device)
结局指标
主要结局
Functional Gait Assessment (FGA)
时间窗: 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).
次要结局
- Four-Stage Balance Test >30s(The assessment requires holding each stance for 10 seconds for a total of 40 seconds to pass.)
- 10-Meter (10M) Walk Test (Measure of Gait Speed)--Number of Participants With Improvement to Normal Gait Speed(During one test session < 3 hours)
- Activities-Specific Balance Confidence Scale (ABC)(Measure was administered only at baseline during one test session <3 hours.)