NCT07854314

Brief Summary

The goal of this observational study is to investigate whether differences in oral proprioceptive sensitivity are associated with differences in kinesthetic acuity of the upper limbs in children. The study examines two aspects of proprioception: oral proprioceptive sensitivity, which refers to the sensory response to proprioceptive stimulation of structures in the mouth, and upper-limb kinesthetic acuity, which refers to the ability to perceive the position or movement of the arms without relying on vision. The study will also explore whether oral and auditory sensory stimuli can produce small, transient visual losses, referred to as visual pseudoscotomas, during a perceptual test based on the Maddox rod. Participants will complete standardized experimental tasks designed to assess upper-limb kinesthetic acuity and oral proprioceptive sensitivity. The study is intended to contribute to the understanding of possible relationships between oral proprioception and proprioception of the upper limbs in children, and of how oral and auditory sensory information may interact with visual perception.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 14, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

September 22, 2026

Last Update Submit

September 26, 2026

Conditions

Keywords

Oral proprioceptive sensitivityProprioceptionKinesthetic acuityTransient visual lossMultisensory integration

Outcome Measures

Primary Outcomes (1)

  • Correlation between upper-limb kinesthetic acuity and oral proprioceptive sensitivity

    Correlation between variability in upper-limb kinesthetic acuity, assessed by the matching task, and variability in the visual response to oral proprioceptive stimulation during the Perceptive Maddox Test.

    Day 1

Secondary Outcomes (3)

  • Occurrence of auditory-induced visual pseudoscotomas

    Day 1

  • Effect of oral proprioceptive stimulation on auditory-induced visual pseudoscotomas

    Day 1

  • Lability of the visual response to oral proprioceptive stimulation

    Day 1

Study Arms (1)

Children younger than 15 years

Children younger than 15 years who participate in the study and undergo assessments of upper-limb kinesthetic acuity and the effect of oral proprioceptive stimulation on visual perception.

Other: Upper-Limb Kinesthetic Acuity AssessmentOther: Effect of Auditory Stimulation on Visual PerceptionOther: Oral Proprioceptive Sensitivity Assessment

Interventions

Participants performed a matching task with both forearms while their eyes were covered. One forearm was positioned by the examiner at a predetermined angle, and the participant moved the other forearm to match its perceived position. The angular position of both forearms was measured using digital inclinometers. The procedure was repeated five times for forearm flexion and five times for extension to assess the variability of upper-limb kinesthetic acuity.

Also known as: Phase 1, Kinesthetic Matching Task
Children younger than 15 years

Participants underwent the Perceptive Maddox Test while receiving bilateral auditory stimulation consisting of simultaneous 500-Hz whistles presented through wireless headphones at approximately 50 dB. Five 10-second sequences were presented. Participants reported whether the red line disappeared completely or partially and, when applicable, indicated the location and changes in location of the visual loss. The occurrence and temporal and spatial characteristics of transient visual losses (visual pseudoscotomas) were recorded.

Also known as: Phase 2, Perceptive Maddox Test and Auditory Stimulation
Children younger than 15 years

The effect of oral proprioceptive stimulation on visual perception was assessed using the Perceptive Maddox Test in combination with auditory stimulation. Oral stimuli consisted of examiner-applied pressure to the vestibular surfaces of the incisors. When an oral stimulus produced a visual effect, calibrated pressure or traction was applied to the incisors using a dynamometer. The temporal and spatial characteristics of the visual response and the variability in the pressure or traction required were recorded.

Also known as: Phase 3, Perceptive Maddox Test and Oral Proprioceptive Stimulation
Children younger than 15 years

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of children younger than 15 years who have all eight permanent incisors and who meet the study eligibility criteria. Participants are recruited among patients of the Hospital Odontològic Universitat de Barcelona (HOUB) and children accompanying their parents or relatives attending the HOUB. The study includes children without neurological, sensory, motor, auditory, visual, or dental conditions that could interfere with the study procedures or the interpretation of the results.

You may qualify if:

  • Children younger than 15 years.
  • Presence of all eight permanent incisors.
  • Voluntary agreement to participate in the study.

You may not qualify if:

  • Neurological, sensory, or motor conditions that could interfere with the performance or interpretation of the study procedures.
  • Treatment with psychotropic medication.
  • Hearing loss in one or both ears.
  • Visual acuity below 20/20 in either eye.
  • Stereoacuity below 120 arc seconds.
  • Vertical phoria greater than 0.75 prism diopters.
  • Strabismus, whether previously operated or not.
  • Ongoing optometric rehabilitation.
  • History of amblyopia.
  • Absence of one or more permanent incisors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Odontològic UB

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Blindness

Interventions

Clinical Trials, Phase I as TopicClinical Trials, Phase II as TopicAcoustic StimulationClinical Trials, Phase III as Topic

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthTherapeuticsSensory Art TherapiesComplementary TherapiesPhysical Stimulation

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 22, 2026

First Posted

October 2, 2026

Study Start

January 14, 2024

Primary Completion

December 14, 2024

Study Completion

December 14, 2024

Last Updated

October 2, 2026

Record last verified: 2026-09

Locations