- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07707089
Evaluation of AI-Mouse Use in Patients With Hand and Wrist Conditions
10 juli 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
15
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jose Berengueres, PhD
- Telefonnummer: +7 778 358 18 26
- E-post: jose.berengueres@nu.edu.kz
Studera Kontakt Backup
- Namn: Dina Kalinina, MD
- Telefonnummer: +77756238719
- E-post: dina.kalinina@nu.edu.kz
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
APDF90 surface electromyography (sEMG) amplitude
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Integrated squared dynamic acceleration
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
1 oktober 2026
Studieregistreringsdatum
Först inskickad
30 juni 2026
Först inskickad som uppfyllde QC-kriterierna
10 juli 2026
Första postat (Faktisk)
16 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1220/02042026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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