- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07707089
Evaluation of AI-Mouse Use in Patients With Hand and Wrist Conditions
10. juli 2026 oppdatert av: Nazarbayev University
People with hand and wrist conditions, such as carpal tunnel syndrome or hand injuries, often experience pain and discomfort when using a computer mouse.
This study will evaluate a new artificial intelligence (AI)-assisted computer input system ("AI-mouse") designed to reduce the amount of hand movement needed during computer tasks.
Participants will complete short computer-based tasks using both a conventional mouse and the AI-assisted system while researchers measure task performance, muscle activity using surface electromyography (EMG), and participants' ratings of pain, physical strain, and usability.
The study aims to determine whether the AI-assisted system can reduce physical effort and muscle load while maintaining effective computer interaction.
Findings may help improve accessible computer technologies and support the development of ergonomic tools for people with hand and wrist impairments.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
15
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jose Berengueres, PhD
- Telefonnummer: +7 778 358 18 26
- E-post: jose.berengueres@nu.edu.kz
Studer Kontakt Backup
- Navn: Dina Kalinina, MD
- Telefonnummer: +77756238719
- E-post: dina.kalinina@nu.edu.kz
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Adults aged 18-65 years
- Diagnosis of a hand or wrist condition, including carpal tunnel syndrome or hand/wrist injury.
- Receiving care at the Hand Surgery Department of the National Scientific Center of Traumatology and Orthopedics.
- Medically stable and assessed by a study physician as able to safely perform light computer-based hand movements.
- Able to understand the study procedures and provide written informed consent.
- Normal or corrected-to-normal vision sufficient to complete computer-based tasks.
Exclusion Criteria:
- Severe pain or acute symptoms that may be aggravated by computer task performance.
- Postoperative restrictions limiting hand or wrist movement.
- Severe motor impairment preventing completion of the study tasks.
- Cognitive or neurological disorders that interfere with understanding study procedures or task performance.
- Uncorrected visual impairment that interferes with computer use.
- Any medical condition that, in the opinion of the study physician, would make participation unsafe.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Conventional Mouse
Participants perform standardized computer pointing tasks using a conventional computer mouse.
Performance (task completion time, error rate, throughput), surface electromyography (EMG) of upper-limb muscles, and participant-reported outcomes (pain, physical strain, and usability) are assessed during task completion.
|
A standard computer mouse used for conventional point-and-click interaction.
Participants complete the same standardized computer tasks as in the experimental condition, allowing direct comparison of task performance, upper-limb muscle activity measured by surface electromyography (EMG), and participant-reported pain, physical strain, and usability.
|
|
Eksperimentell: AI-Mouse (Preview-Accept-Discard [PAD] System)
Participants perform the same standardized computer tasks using the AI-Mouse, a predictive human-computer interaction system based on the Preview-Accept-Discard (PAD) paradigm.
The system generates AI-assisted action suggestions that can be accepted or discarded using minimal keyboard input, reducing cursor movement.
Performance, surface electromyography (EMG), and participant-reported outcomes (pain, physical strain, and usability) are assessed during task completion.
|
A non-invasive computer input system that uses artificial intelligence to predict the user's intended on-screen action.
Instead of relying primarily on continuous cursor movement and mouse clicking, the system presents predicted actions that participants can preview, accept, or discard using minimal keyboard input.
The intervention is designed to reduce repetitive hand movements during computer interaction while preserving user control.
Participants complete standardized computer tasks using the system during a single study session lasting less than four minutes.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
APDF90 surface electromyography (sEMG) amplitude
Tidsramme: Baseline (during each intervention condition on Day 1)
|
90th percentile amplitude probability distribution function (APDF90) of the processed sEMG envelope recorded from selected upper-limb muscles during standardized computer tasks.
|
Baseline (during each intervention condition on Day 1)
|
|
Muscular rest time
Tidsramme: Baseline (during each intervention condition on Day 1)
|
Percentage of task duration during which the processed sEMG envelope remained below the predefined muscular-rest threshold of 2 µV.
|
Baseline (during each intervention condition on Day 1)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Integrated squared dynamic acceleration
Tidsramme: Baseline (during each intervention condition on Day 1)
|
Cumulative dynamic movement workload measured by tri-axial accelerometry and expressed as integrated squared dynamic acceleration (mG²·s).
|
Baseline (during each intervention condition on Day 1)
|
|
90th percentile dynamic acceleration
Tidsramme: Baseline (during each intervention condition on Day 1)
|
Peak dynamic movement intensity measured by tri-axial accelerometry and expressed as the 90th percentile of dynamic acceleration (mG).
|
Baseline (during each intervention condition on Day 1)
|
|
Task completion time
Tidsramme: Baseline (during each intervention condition on Day 1)
|
Time required to complete the standardized computer task using the conventional mouse and the AI-assisted computer input system.
|
Baseline (during each intervention condition on Day 1)
|
|
Error rate
Tidsramme: Baseline (during each intervention condition on Day 1)
|
Percentage of incorrect target selections during the standardized computer task
|
Baseline (during each intervention condition on Day 1)
|
|
Self-reported pain
Tidsramme: Immediately after each intervention condition on Day 1
|
Participant-reported hand and wrist pain after completing each intervention condition, assessed using a numeric rating scale
|
Immediately after each intervention condition on Day 1
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. oktober 2026
Datoer for studieregistrering
Først innsendt
30. juni 2026
Først innsendt som oppfylte QC-kriteriene
10. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1220/02042026
Plan for individuelle deltakerdata (IPD)
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NEI
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