A Pilot Study to Explore the Effects of Lower-Leg Mechanical Tactile Sensory Stimulation on the Gait Speed of Mildly Cognitively Impaired Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)
研究概览
简要总结
The primary aim of this pilot study is to investigate the effect of Walkasins, a wearable lower-limb sensory prosthesis, on the gait speed and balance function of participants with mild cognitive impairment as measured by the Saint Louis University Mental Status (SLUMS) Examination.
详细描述
The Walkasins system is one of a growing number of wearable devices that use various modalities of neuromodulation, defined as "the alteration of nerve activity through targeted delivery of a stimulus . . . to specific neurological sites in the body" (https://www.neuromodulation.com/). Because these technologies are relatively new, innovative applications of their use in various patient populations may lead to improvements in the care and quality of life of individuals who suffer from these life-altering diagnoses.
Previous studies of Walkasins have shown that individuals with peripheral neuropathy who have gait and balance problems walk faster with the Walkasins device. This increase may be related to an improved automaticity of gait function, which decreases the need for cognitive attention to the walking task, which is known to slow down gait. Individuals with mild cognitive impairment commonly show slow gait speeds, likely due to a decline in executive function. There is a reason to think that sensory stimuli from the Walkasins device can improve the automaticity of gait in these individuals and thereby enhance gait speed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory person who is at least 65 years of age
- •Ability to understand and provide informed consent
- •Ability to perceive vibrations from the Walkasins Haptic Module
- •Ability to complete the functional outcome measures without the use of an assistive device
- •Foot size that allows the Walkasins to function appropriately
- •Mild Cognitive Impairment (MCI) as measured by the Saint Louis University Mental Status (SLUMS) Exam (scores between 20 and 24 + or -2 for those with less than a high school education and scores between 21-26 + or -2 for those who graduated from high school, which indicate mild cognitive impairment) and/or a diagnosis of MCI (or related term) in the person's medical record
- •Slow gait speed (<1m/second or slightly faster, provided all other criteria are met)
排除标准
- •Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
- •Self-reported acute thrombophlebitis including deep vein thrombosis
- •Untreated lymphedema
- •Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
- •Untreated fractures in the foot and ankle
- •Self-reported severe peripheral vascular disease
- •Other neurological conditions that impact walking (e.g., peripheral neuropathy)
- •Weighs more than 300 pounds
结局指标
主要结局
Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)
时间窗: 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)
The 4-meter gait speed test measures the number of seconds it takes a person to walk four meters on a level surface. Gait speed measures are a significant indicator of a person's functional mobility. Higher gait speeds (meters/second) are better than lower gait speeds and are indicative of better functional mobility. (Generally, gait speeds less than 1m/second are considered slow.)
次要结局
- Short Physical Performance Battery (SPPB)(Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition))
- Timed Up and Go (TUG)(Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition))
- Timed Up and Go Cognitive (TUG-COG)(Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition))
- Falls Efficacy Scale(Once During 1 Session <1.5 Hours)