Randomized, Sham-Controlled, Multicenter Investigation of the Leia Sensory Prosthesis on Gait and Balance in Peripheral Neuropathy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Functional Gait Assessment (FGA) total score
研究概览
简要总结
This study will evaluate a wearable device intended to support balance and gait in adults with peripheral neuropathy. Participants will use the device for a defined period, and outcomes related to safety, usability, and functional performance will be assessed.
详细描述
This clinical investigation will assess a non-invasive wearable device designed to enhance gait and balance in individuals with peripheral neuropathy. The study will evaluate whether the device can improve balance and gait stability during daily activities, and will also examine safety, comfort, and overall user acceptability over the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants and outcomes assessors are masked to group allocation (active vs. sham). A subset of care providers responsible for device setup and allocation is unblinded due to practical requirements, while other care providers interacting with participants remain blinded whenever feasible. Investigators at the site have access to allocation information if needed for safety or clinical decision-making.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study procedure
- •Adults ≥ 18 years
- •Clinical diagnosis of peripheral neuropathy, confirmed per site procedures and neurophysiological testing (e.g. NCV)
- •Gait or balance difficulties as self-reported and confirmed by Functional Gait Assessment (FGA score ≤ 23) and/or single-leg stance < 30 seconds
- •Able to walk without walking aids
- •Stable supplements and medications ≥ 1 month before baseline and willing to maintain stability during the investigation (same dosage and same medication within the last month)
- •Willingness and ability to attend weekly sessions, perform home use, and return for follow-up
排除标准
- •Untreated/unhealed lesion of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near product use (e.g., untreated lymphedema, phlebitis, thrombo-phlebitis or varicose veins)
- •Untreated/unhealed fractures in the foot and ankle
- •Cancerous growth in the planned treatment area
- •Severe peripheral vascular disease (e.g., gangrene)
- •Cognitive impairment that precludes informed consent or device use
- •Implanted electrical devices or pacemakers
- •Lower-limb orthoses/braces that cannot be removed for assessments
- •Pregnant or breast-feeding females
- •Usage of other medical devices for the relief of neuropathic symptoms during the study
- •Current participation in any other clinical study using an investigational device or investigational drug
- •Orthopedic conditions substantially limiting gait (e.g., failed back surgery syndrome (FBSS), recent hip or knee replacement, unstable fractures) as judged by the investigator
- •For patients who have been randomized in the active treatment group only: Incapability to perceive somatotopic sensations (tested at screening by MYNERVA staff)
研究组 & 干预措施
Active Device
Participants use the active wearable device during the study period.
干预措施: Active wearable device (Device)
Sham Device
Participants use a sham version of the wearable device without active functionality.
干预措施: Sham wearable device (Device)
结局指标
主要结局
Functional Gait Assessment (FGA) total score
时间窗: Change in Functional Gait Assessment (FGA) total score from baseline (day 0) to day 56.
The FGA is a validated clinical scale that assesses gait function and balance under various walking tasks.
Change From Baseline in Functional Gait Assessment (FGA) Total Score
时间窗: 2 months
Change in Functional Gait Assessment (FGA) total score (0-30 points) from baseline to 2 months. Higher scores indicate better gait and balance performance.
次要结局
- Functional Gait Assessment (FGA) total score(From baseline (day 0) to the end of the supervised period (day 28), change from day 28 to day 56, and evaluation of evolution across all timepoints, with and without stimulation)
- Timed-up and Go (TUG) in seconds(Change from Baseline to day 56)
- Neuropathic pain symptoms (NPSI questionnaire)(Change from baseline to each of the follow-up time points (day 7, 14, 28, 35, 42, 49, 56 and 80))
- Quality of life (NORFOLK QOL-DN, EQ-5D-5L questionnaire)(Change from baseline to day 28, day 56 and day 80)
- Sensory function - Monofilament test(Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28 and 56))
- Sensory function - Rydel-Seiffer tuning fork test(Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28, and 56))
- Sensory function - Sudoscan (subset of patients)(Change from baseline to day 56)
- Impact on fall risk: fall questionnaire(Change from baseline to day 28, day 56 and day 80)
- Neuroimaging (MRI) (subset of patients)(Change from baseline to day 56)
- Treatment compliance(Through home use phase of 4 weeks)
- Objective gait parameters (Movement Lab): step length in cm(Baseline, day 28 and day 56)
- Objective gait parameters (Movement Lab): step width in cm(Baseline, day 28 and day 56)
- Objective gait parameters (Movement Lab): center of mass sway in cm(Baseline, day 28 and day 56)
- Objective gait parameters (Movement Lab): heel-strike force in Newton(Baseline, day 28 and day 56)