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Multimodal Tracking of Therapy Activity and Effort During Rehabilitation

27 de julho de 2026 atualizado por: ETH Zurich

Pilot Feasibility Study of Rehabilitation Therapy Content and Effort Logging

This study looks at whether everyday rehabilitation therapy sessions can be recorded and measured in a more complete, objective way. Today, therapists usually document sessions by hand, and the notes can vary a lot from one therapist to another. This makes it hard to track exactly what was done during a session and how much effort it took.

In this study, adults receiving neurorehabilitation (for example after a stroke, or with Parkinson's disease, cerebral palsy, spinal cord injury, or ALS) wear two small, non-invasive wrist sensors during their normal therapy. The sensors measure things like heart rate, breathing, skin temperature, and movement. A camera records body movement during the session, and the therapist can turn on an audio recorder that captures their spoken instructions. After each activity, participants rate how hard it felt.

Nothing about the therapy itself changes. The sensors, camera, and audio recording are used only to collect information - they do not guide treatment or affect any clinical decisions. Each participant takes part in three routine therapy sessions.

The goal is to find out whether this combination of sensor, video, and voice information can be collected reliably during normal care, and to compare how the recorded effort matches what therapists and patients report. The study does not provide direct medical benefit to participants, but it may help make future therapy documentation more consistent, objective, and less time-consuming for therapists.

Visão geral do estudo

Status

Ativo, não recrutando

Descrição detalhada

Rehabilitation therapy documentation is predominantly manual and therapist-dependent, with variation in structure, timing, and level of detail across practitioners. Existing records support clinical communication but do not systematically capture the temporal structure or quantitative characteristics of therapy sessions, such as movement intensity, physiological effort, and activity type. This feasibility study evaluates whether a multimodal logging approach can capture this information reliably during routine neurorehabilitation without disrupting clinical workflows.

The approach combines three synchronized data streams. Wrist-worn, non-invasive CE-marked sensors continuously record physiological and movement signals (including photoplethysmography-derived heart rate and respiration, skin temperature, electrodermal activity, and acceleration). A single, fixed-position camera records observable movement during the session, from which automated computer-vision methods derive motion representations such as joint coordinates and abstract skeletal or mesh-based models; these derived representations contain biomechanical coordinate data only and do not retain identifying visual features. A therapist-controlled audio recorder captures spoken instructions and task descriptions to provide contextual annotation of session content.

Each participant completes three routine therapy sessions within an approximately two-week period at a single rehabilitation center. Each session follows an identical structure: a five-minute baseline resting measurement, the routine therapy session with continuous sensor, video, and voice recording, brief self-reported effort ratings after each activity, and a five-minute recovery resting measurement. Therapy is delivered according to standard clinical practice; the recording systems are used only for data collection and provide no real-time output, feedback, or therapeutic guidance to the therapist or participant.

Because the study is exploratory and observational, no hypothesis testing is planned. Analyses are descriptive and focus on data completeness, signal quality, and the practical integration of the recording systems into routine care, together with descriptive associations between therapist-reported effort, patient-reported effort, and sensor- and video-derived measures of activity and physiological load. Recordings are captured electronically, coded under a study ID, and stored on secure access-restricted institutional infrastructure.

Tipo de estudo

Observacional

Inscrição (Estimado)

10

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.

Locais de estudo

    • Canton of Zurich
      • Zurich, Canton of Zurich, Suíça, 8001
        • Nextherapy AG

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

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Adults undergoing routine neurorehabilitation for neurological motor impairment at a specialized rehabilitation center. Eligible conditions include stroke, cerebral palsy, Parkinson's disease, spinal cord injury, and amyotrophic lateral sclerosis. Participants are recruited consecutively from routine clinical practice at the study site and are capable of providing informed consent and participating in a therapy session of at least 30 minutes. A balanced distribution of male and female participants is pursued through consecutive recruitment of eligible patients.

Descrição

Inclusion Criteria:

  • Signed informed consent Age ≥18 years Clinical diagnosis of a neurological motor impairment (stroke, cerebral palsy, Parkinson's disease, spinal cord injury, or amyotrophic lateral sclerosis) Ability to participate in a therapy session of at least 30 minutes

Exclusion Criteria:

  • Acute infection or unstable medical condition Severe cognitive or communicative impairment preventing consent or participation Skin conditions preventing sensor placement Implanted cardiac devices that may interfere with PPG or EDA recordings Concurrent participation in another interventional clinical trial

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

Coortes e Intervenções

Grupo / Coorte
Routine Neurorehabilitation Cohort

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Feasibility of Multimodal Therapy Session Logging
Prazo: Through study participation, across three therapy sessions per participant completed within an approximately two-week period
Feasibility is assessed by successful capture of synchronized multimodal data during routine therapy sessions, evaluated through data completeness and signal quality across three data streams: (1) wrist-worn wearable signals (PPG-derived heart rate and respiration rate, skin temperature, electrodermal activity, acceleration); (2) video-based motion estimation; and (3) the therapist-controlled voice recording system. Reported descriptively as the proportion of sessions with usable data and the proportion of recording time yielding analyzable signal per data stream
Through study participation, across three therapy sessions per participant completed within an approximately two-week period

Colaboradores e Investigadores

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

Patrocinador

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 (Real)

1 de junho de 2026

Conclusão Primária (Estimado)

30 de dezembro de 2026

Conclusão do estudo (Estimado)

30 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

27 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de julho de 2026

Primeira postagem (Real)

31 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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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