Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders (FRONTIER)
2026년 8월 1일 업데이트: PIETRO MORTINI, Università Vita-Salute San Raffaele
FRONTIER - Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders.
Development of a soft robotic device for rehabilitation and assistance of the upper limb for people with neurological disorders (FRONTIER)
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Pietro Mortini, Prof. MD
- 전화번호: +39 0226435568
- 이메일: sincinelli.laura@hsr.it
연구 장소
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Milan
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Milan, Milan, 이탈리아, 20132
- IRCCS Ospedale San Raffaele
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연락하다:
- Laura Sincinelli
- 전화번호: +39 0226435568
- 이메일: sincinelli.laura@hsr.it
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
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
Patients:
- 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)
Exclusion Criteria:
Healthy volunteers:
- Age < 18 or > 80 years
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
Patients:
- 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: FRONTIER Soft Exoskeleton Testing
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Each participant (both healthy volunteers and patients) will take part in one single testing session, structured as follows:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Usability of the FRONTIER Soft Exoskeleton as Assessed by the System Usability Scale (SUS) Total Score
기간: Day 1. Immediately after completion of the single testing session
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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.
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Day 1. Immediately after completion of the single testing session
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Difference in Mean Normalized Surface Electromyography (sEMG) Amplitude Between Robotic-Assisted and Unassisted Movements
기간: Day 1. During the single testing session
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Muscle activity during upper-limb movements will be recorded using surface electromyography (sEMG) under two conditions: with and without assistance from the FRONTIER soft exoskeleton.
sEMG amplitude will be quantified using the root mean square (RMS) and normalized to the maximum voluntary contraction, expressed as a percentage of maximum voluntary contraction (%MVC).
For each participant, the mean normalized RMS amplitude across the predefined muscles and movement repetitions will be calculated for each condition.
The reported outcome will be the within-participant difference between the robotic-assisted and unassisted conditions.
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Day 1. During the single testing session
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Mean Difference in Upper-Limb Range of Motion Between Robotic-Assisted and Unassisted Movements
기간: Day 1. During the single testing session
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Upper-limb range of motion will be measured during shoulder, elbow, and forearm movements performed with and without assistance from the FRONTIER soft exoskeleton.
For each movement, range of motion will be calculated as the difference between the maximum and minimum joint angles recorded using inertial sensors.
For each participant, the differences in range of motion between the robotic-assisted and unassisted conditions will be averaged across all predefined movements to obtain a single mean difference.
Positive values indicate a greater overall range of motion with robotic assistance.
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Day 1. During the single testing session
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NASA Task Load Index (NASA-TLX) Overall Workload Score After Robotic-Assisted Testing
기간: Day 1. Immediately after completion of the robotic-assisted testing session
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Perceived workload associated with use of the FRONTIER soft exoskeleton will be measured using the NASA Task Load Index (NASA-TLX).
The questionnaire assesses six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration.
Each dimension is rated on a scale from 0 to 100 points.
The overall workload score will be calculated as the mean of the six dimension scores and will range from 0 to 100 points.
Higher scores indicate greater perceived workload.
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Day 1. Immediately after completion of the robotic-assisted testing session
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Mean Difference in Borg Category-Ratio 10 Fatigue Score Between Robotic-Assisted and Unassisted Movements
기간: Day 1. Immediately after each predefined movement performed with and without robotic assistance during the single testing session
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Perceived fatigue will be measured using the Borg Category-Ratio 10 scale (Borg CR10) immediately after each predefined shoulder, elbow, and forearm movement performed with and without assistance from the FRONTIER soft exoskeleton.
Scores range from 0, indicating no fatigue, to 10, indicating maximal fatigue.
For each participant, Borg CR10 scores will be averaged across the predefined movements for each condition.
The reported outcome will be the within-participant difference between the robotic-assisted and unassisted conditions.
Positive values indicate greater perceived fatigue with robotic assistance, whereas negative values indicate lower perceived fatigue with robotic assistance.
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Day 1. Immediately after each predefined movement performed with and without robotic assistance during the single testing session
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Device-Related Adverse Events During the Single Testing Session
기간: Day 1. From device fitting through completion of the single testing session
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Safety of the FRONTIER soft exoskeleton will be assessed by recording any device-related adverse events occurring during the testing session.
Adverse events may include pain, skin irritation, pressure-related symptoms, or any other undesirable medical occurrence considered related to use of the device.
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Day 1. From device fitting through completion of the single testing session
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2026년 10월 30일
연구 완료 (추정된)
2026년 12월 31일
연구 등록 날짜
최초 제출
2026년 7월 14일
QC 기준을 충족하는 최초 제출
2026년 8월 1일
처음 게시됨 (실제)
2026년 8월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 1일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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