NCT07707089

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress34%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 30, 2026

Last Update Submit

July 10, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • APDF90 surface electromyography (sEMG) amplitude

    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

    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)

Secondary Outcomes (5)

  • Integrated squared dynamic acceleration

    Baseline (during each intervention condition on Day 1)

  • 90th percentile dynamic acceleration

    Baseline (during each intervention condition on Day 1)

  • Task completion time

    Baseline (during each intervention condition on Day 1)

  • Error rate

    Baseline (during each intervention condition on Day 1)

  • Self-reported pain

    Immediately after each intervention condition on Day 1

Study Arms (2)

Conventional Mouse

ACTIVE COMPARATOR

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.

Device: Conventional Computer Mouse

AI-Mouse (Preview-Accept-Discard [PAD] System)

EXPERIMENTAL

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.

Device: AI-Assisted Computer Input System

Interventions

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.

AI-Mouse (Preview-Accept-Discard [PAD] System)

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.

Conventional Mouse

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carpal Tunnel SyndromeWounds and InjuriesHand InjuriesWrist Injuries

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsArm Injuries

Central Study Contacts

Jose Berengueres, PhD

CONTACT

Dina Kalinina, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 16, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share