- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Canton of Zurich
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Zurich, Canton of Zurich, 스위스, 8001
- Nextherapy AG
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Routine Neurorehabilitation Cohort
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of Multimodal Therapy Session Logging
기간: Through study participation, across three therapy sessions per participant completed within an approximately two-week period
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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
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Through study participation, across three therapy sessions per participant completed within an approximately two-week period
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .