Wearable Sensory Prostheses to Improve Neuromuscular Coordination, Walking Function, and Real-World Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Activity Score--Metabolic Equivalents (METs)
研究概览
简要总结
The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN). The main question it aims to answer is whether Walkasins enhances habitual activity patterns in adults with peripheral neuropathy.
Participants will do the following as part of the study:
- Complete a sensation and balance assessment to determine eligibility for the study.
- Answer questions about their medical history, physical function, balance confidence, and sleep.
- Perform various balance and walking tasks on three separate occasions. One of the tests involves walking for six minutes without a cane or walker.
- Wear an activPAL activity monitor for ten days on three separate occasions and return it to the researcher as directed.
- Wear Walkasins for ten weeks as part of their daily routine. Walkasins consists of two parts: 1) an insole that fits inside the shoe and 2) a strap that secures around the ankle.
详细描述
This will be a prospective within-participant study design conducted over a period of one year. After providing informed consent, all participants will undergo a battery of instrumented mobility assessments (e.g., 6-minute walk test [6MWT], Functional Gait Assessment [FGA], etc.), questionnaires, and a 10-day habitual physical activity observation period, wearing an electronic event logger to derive the primary outcomes. This initial (baseline) assessment, without the sensory assistance of the Walkasins, will allow participants to serve as their own control. Assessment and observation periods will be repeated at the dispensing of the Walkasins device and after participants have acclimated to daily use, 10 weeks after participants have begun wearing the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 60 years of age or older
- •Have a diagnosis of PN with plantar sensory loss
- •Demonstrate balance impairment, defined as a Single-Leg Stance time of <23 seconds
- •Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted)
- •Be willing to use the Walkasins device as recommended
- •Be willing to participate in all aspects of physical activity monitoring and study assessments
排除标准
- •Under 60 years old
- •Do not have a diagnosis of PN with plantar sensory loss
- •Self-reported acute thrombophlebitis, including deep vein thrombosis
- •Self-reported severe peripheral vascular disease
- •Untreated lymphedema
- •Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
- •Self-reported, untreated fractures in the foot and ankle
- •Other neurological or musculoskeletal conditions that moderately or severely impact walking
- •Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
- •Weight of more than 300 pounds
- •Inability to perceive vibration from Walkasins Haptic Module
- •Do not demonstrate balance impairments, defined as a Single-Leg Stance time of <23 seconds
研究组 & 干预措施
Walkasins Users
After the baseline visit and activity monitoring, users will receive Walkasins. They will use the device for 10 weeks during which they will also wear an activPAL activity monitor for ten days on at the beginning and end of their Walkasins use.
干预措施: External, lower limb sensory prosthesis (Device)
结局指标
主要结局
Activity Score--Metabolic Equivalents (METs)
时间窗: Over a period of ~12 weeks
The Activity Score, expressed in metabolic equivalents (METs), reflects the overall intensity of physical activity performed. (One MET is defined as the energy a person uses when resting or sitting still.) Higher MET values indicate greater energy expenditure and higher levels of physical activity, while lower values suggest reduced activity intensity and increased sedentary behavior.
Step Count
时间窗: Over a period of ~12 weeks
Step count reflects the total number of steps accumulated over a given period and serves as an indicator of overall daily ambulatory activity. Lower step counts are associated with reduced physical activity levels and decreased functional mobility.
Total Sedentary Time
时间窗: Over a period of ~12 weeks
Total sedentary time reflects the individual's overall inactivity during the day. Prolonged sedentary behavior may contribute to deconditioning, decreased functional capacity, and increased risk for chronic disease.
6-Minute Walk Test--Phase Coordination Index (PCI)
时间窗: Baseline, Walkasins Initiation, Follow-up (Week 10)
The 6 Minute Walk Test is an exercise test used to evaluate aerobic capacity and endurance. The distance a subject walks in six minutes is the outcome by which to compare changes in performance capacity. Participants will wear sensors during the test that will allow for calculation of Phase Coordination Index (PCI) scores. A PCI score closer to zero indicates better bilateral coordination or better phase generation accuracy and/or consistency within the gait cycle.
次要结局
- 10-Meter Walk Test(Baseline, Walkasins Initiation, Follow-up (Week 10))
- 2-Minute Dual-Task Walk (2MDTW)(Baseline, Walkasins Initiation, Follow-up (Week 10))
- Timed Up and Go (TUG)(Baseline, Walkasins Initiation,)
- Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)(Baseline, Walkasins Initiation, Follow-up (Week 10))
- Single Leg Stance (SLS)(Baseline, Walkasins Initiation, Follow-up (Week 10))
- Functional Gait Assessment (FGA)(Baseline, Walkasins Initiation, Follow-up (Week 10))
- International Physical Activity Questionnaire (IPAQ) or IPAQ for Elderly Adults (IPAQ-E)(Baseline, Walkasins Initiation, Follow-up (Week 10))
- Activities-specific Balance Confidence (ABC) Scale(Baseline, Walkasins Initiation, Follow-up (Week 10))
- PROMIS PROWalk(Baseline, Walkasins Initiation, Follow-up (Week 10))
- PROMIS Scale v2.0 - Pain Intensity 3a(Baseline, Walkasins Initiation, Follow-up (Week 10))
- PROMIS Sleep-Related Impairment (SRI) and Sleep Disturbance(Baseline, Walkasins Initiation, Follow-up (Week 10))