Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders (FRONTIER)
2026年8月1日 更新者：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)
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Pietro Mortini, Prof. MD
- 電話番号：+39 0226435568
- メール：sincinelli.laura@hsr.it
研究場所
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Milan
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Milan、Milan、イタリア、20132
- IRCCS Ospedale San Raffaele
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コンタクト：
- Laura Sincinelli
- 電話番号：+39 0226435568
- メール：sincinelli.laura@hsr.it
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：デバイスの実現可能性
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Usability of the FRONTIER Soft Exoskeleton as Assessed by the System Usability Scale (SUS) Total Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in Mean Normalized Surface Electromyography (sEMG) Amplitude Between Robotic-Assisted and Unassisted Movements
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2026年10月30日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年7月14日
QC基準を満たした最初の提出物
2026年8月1日
最初の投稿 (実際)
2026年8月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月6日
QC基準を満たした最後の更新が送信されました
2026年8月1日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。