- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07739134
Multimodal Tracking of Therapy Activity and Effort During Rehabilitation
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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Sveitsi, 8001
- Nextherapy AG
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
Routine Neurorehabilitation Cohort
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Feasibility of Multimodal Therapy Session Logging
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- BASEC-Nr: 2025-02397
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .