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Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders (FRONTIER)

1 de agosto de 2026 atualizado por: 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)

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Itália
    • Milan
      • Milan, Milan, Itália, 20132
        • IRCCS Ospedale San Raffaele
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Viabilidade do dispositivo
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: FRONTIER Soft Exoskeleton Testing
Dispositivo: FRONTIER Soft Exoskeleton

Each participant (both healthy volunteers and patients) will take part in one single testing session, structured as follows:

  1. Unassisted condition: subjects will perform a set of standardized upper limb movements (shoulder, elbow, and hand) without robotic assistance.
  2. Assisted condition (robot active): the same set of movements will be repeated with the support of the FRONTIER exoskeleton.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Usability of the FRONTIER Soft Exoskeleton as Assessed by the System Usability Scale (SUS) Total Score
Prazo: 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.
Day 1. Immediately after completion of the single testing session

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Difference in Mean Normalized Surface Electromyography (sEMG) Amplitude Between Robotic-Assisted and Unassisted Movements
Prazo: Day 1. During the single testing session
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.
Day 1. During the single testing session
Mean Difference in Upper-Limb Range of Motion Between Robotic-Assisted and Unassisted Movements
Prazo: Day 1. During the single testing session
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.
Day 1. During the single testing session
NASA Task Load Index (NASA-TLX) Overall Workload Score After Robotic-Assisted Testing
Prazo: Day 1. Immediately after completion of the robotic-assisted testing session
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.
Day 1. Immediately after completion of the robotic-assisted testing session
Mean Difference in Borg Category-Ratio 10 Fatigue Score Between Robotic-Assisted and Unassisted Movements
Prazo: Day 1. Immediately after each predefined movement performed with and without robotic assistance during the single testing session
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.
Day 1. Immediately after each predefined movement performed with and without robotic assistance during the single testing session
Device-Related Adverse Events During the Single Testing Session
Prazo: Day 1. From device fitting through completion of the single testing session
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.
Day 1. From device fitting through completion of the single testing session

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Università Vita-Salute San Raffaele

Colaboradores

IRCCS San Raffaele

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

30 de outubro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

14 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de agosto de 2026

Primeira postagem (Real)

6 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CET 86-2026

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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