FRONTIER - Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Usability of the FRONTIER Soft Exoskeleton as Assessed by the System Usability Scale (SUS) Total Score
研究概览
简要总结
Development of a soft robotic device for rehabilitation and assistance of the upper limb for people with neurological disorders (FRONTIER)
详细描述
Wearable robotics is a rapidly expanding field, with robotic devices increasingly being explored and integrated into neurorehabilitation practice. Robotic exoskeletons based on motor learning principles have been introduced to support rehabilitation interventions and are available in a wide range of configurations, including soft or rigid architectures, systems with single or multiple degrees of freedom, and devices targeting either the upper or lower limbs.
In this context, FRONTIER aims to develop, integrate, and evaluate a soft robotic exoskeleton designed to support upper-limb motor function in individuals with chronic neurological impairments resulting from acquired brain injury (ABI). The device is intended to assist both isolated and coordinated multi-joint movements involving proximal upper-limb segments, including the shoulder and elbow, and distal segments, including the hand.
The primary objective of FRONTIER is to evaluate the clinical usability of the soft robotic exoskeleton prototype, which integrates existing robotic modules, and to support the development of synergistic control algorithms coordinating assistance across multiple upper-limb joints. The study will evaluate the usability, safety, and acceptability of the system during a single testing session in a clinical rehabilitation setting. The findings will provide preliminary information to guide further development and future evaluation of the device in neurorehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •Male and female participants
- •Age ≥ 18 and ≤ 80 years
- •Absence of neurological, neuromuscular, or orthopedic conditions that may affect upper-limb use
- •Willingness to comply with study procedures and to sign the informed consent form
- •Ability to understand and sign the informed consent form
- •Male and female participants
- •Age ≥ 18 and ≤ 80 years
- •Clinical diagnosis of acquired brain injury (ABI), in the chronic phase (≥ 6 months after the event)
- •Persistent upper-limb motor impairment
- •Medically stable condition and ability to sit upright or stand for the duration of the testing session
- •Willingness to participate in the study intervention
- •Ability to understand and sign the informed consent form
- •Preserved cognitive function, assessed by the Mini-Mental State Examination (MMSE ≥ 24/30)
排除标准
- •Healthy volunteers:
- •Age < 18 or > 80 years
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
- •Age < 18 or > 80 years
- •Cognitive impairment interfering with the understanding of the tasks or study protocol, assessed by the Mini-Mental State Examination (MMSE < 24/30)
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
研究组 & 干预措施
FRONTIER Soft Exoskeleton Testing
干预措施: FRONTIER Soft Exoskeleton (Device)
结局指标
主要结局
Usability of the FRONTIER Soft Exoskeleton as Assessed by the System Usability Scale (SUS) Total Score
时间窗: Day 1. Immediately after completion of the single testing session
Device usability will be measured using the 10-item System Usability Scale (SUS) following use of the FRONTIER soft exoskeleton prototype. Each item is rated on a 5-point Likert scale, and item scores are converted and combined to obtain a total score ranging from 0 to 100 points. Higher scores indicate greater perceived usability of the prototype. Device usability represents the primary feasibility-related outcome of the study and does not assess changes in participants' health status. SUS total scores will be reported separately for healthy volunteers and participants with chronic acquired brain injury.
次要结局
- Mean Difference in Borg Category-Ratio 10 Fatigue Score Between Robotic-Assisted and Unassisted Movements(Day 1. Immediately after each predefined movement performed with and without robotic assistance during the single testing session)
- Difference in Mean Normalized Surface Electromyography (sEMG) Amplitude Between Robotic-Assisted and Unassisted Movements(Day 1. During the single testing session)
- Mean Difference in Upper-Limb Range of Motion Between Robotic-Assisted and Unassisted Movements(Day 1. During the single testing session)
- NASA Task Load Index (NASA-TLX) Overall Workload Score After Robotic-Assisted Testing(Day 1. Immediately after completion of the robotic-assisted testing session)
- Device-Related Adverse Events During the Single Testing Session(Day 1. From device fitting through completion of the single testing session)
研究者
PIETRO MORTINI
Full Professor, M.D., Director, Post-graduate School of Neurosurgery Università Vita-Salute S. Raffaele
Università Vita-Salute San Raffaele