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Multimodal Tracking of Therapy Activity and Effort During Rehabilitation

27 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

10

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Routine Neurorehabilitation Cohort

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of Multimodal Therapy Session Logging
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

30 dicembre 2026

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

27 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 luglio 2026

Primo Inserito (Effettivo)

31 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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