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Multimodal Tracking of Therapy Activity and Effort During Rehabilitation

27 de julio de 2026 actualizado 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.

Descripción general del estudio

Estado

Activo, no reclutando

Descripción detallada

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 estudio

De observación

Inscripción (Estimado)

10

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Routine Neurorehabilitation Cohort

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of Multimodal Therapy Session Logging
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2026

Finalización primaria (Estimado)

30 de diciembre de 2026

Finalización del estudio (Estimado)

30 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

27 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de julio de 2026

Publicado por primera vez (Actual)

31 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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