NCT07739134

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Multimodal Therapy Session Logging

    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

Study Arms (1)

Routine Neurorehabilitation Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nextherapy AG

Zurich, Canton of Zurich, 8001, Switzerland

Location

MeSH Terms

Conditions

StrokeCerebral PalsySpinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Damage, ChronicSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 31, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations