NCT07636603

Brief Summary

The goal of this clinical trial is to learn how experimentally induced movement-related threat affects emotional, autonomic, and motor responses in healthy adults. The main questions it aims to answer are: Does movement-related threat change walking performance or upper-limb pointing movements? Are these effects moderated by participants' level of kinesiophobia? Does movement-related threat increase apprehension or alter heart rate variability responses? Participants will complete two experimental conditions during one session: a control condition and an experimental condition. In both conditions, inactive transcutaneous electrical nerve stimulation electrodes will be placed in the lumbar region. In the experimental condition, participants will receive verbal suggestions about discomfort, movement-evoked pain, and potential unpredictable electrical stimulation to create the threat of pain associated with movement. Participants will complete a baseline assessment of kinesiophobia, followed by walking and pointing tasks, while perceived apprehension and autonomic responses are assessed.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

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 Start

First participant enrolled

November 3, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

May 21, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Pain-related fearThreat manipulationAnxietyMotor controlMovement-related fearPointing taskWalking taskKinesiophobia

Outcome Measures

Primary Outcomes (4)

  • Difference in walking speed between the control electrode and experimental electrode conditions

    Walking speed will be assessed during the walking task using the GAITRite electronic walkway system. Walking speed will be expressed in meters per second and compared between the control and experimental electrode conditions.

    Day 1, during the walking task under each randomized electrode condition

  • Difference in walking cadence between the control electrode and experimental electrode conditions

    Walking cadence will be assessed during the walking task using the GAITRite electronic walkway system. Walking cadence will be expressed in steps per minute and compared between the control and experimental electrode conditions.

    Day 1, during the walking task under each randomized electrode condition

  • Difference in walking stride length between the control electrode and experimental electrode conditions

    Walking stride length will be assessed during the walking task using the GAITRite electronic walkway system. Walking stride length will be expressed in meters and compared between the control and experimental electrode conditions.

    Day 1, during the walking task under each randomized electrode condition

  • Difference in upper-limb pointing movement time between the control electrode and experimental electrode conditions

    Upper-limb pointing movement time will be assessed during the pointing task using a custom Arduino-based device. Movement time will correspond to the interval between finger lift-off from the starting position and contact with the illuminated target, and will be expressed in milliseconds. Movement time will be assessed across four target locations: ipsilateral 80%, ipsilateral 110%, contralateral 80%, and contralateral 110% of arm length. Movement time will be compared between the control and experimental electrode conditions.

    Day 1, during the upper-limb pointing task under each randomized electrode condition

Secondary Outcomes (3)

  • Kinesiophobia

    Baseline

  • Change from Baseline in heart rate variability

    Day 1: baseline, during the control electrode condition, and during the experimental electrode condition

  • Change from baseline in perceived apprehension

    Day 1: baseline, during the control electrode condition, and during the experimental electrode condition

Other Outcomes (1)

  • Brief Pain Inventory

    Baseline

Study Arms (2)

Control electrodes

SHAM COMPARATOR

Participants were exposed to control electrodes described as safe and reliable, without threat-related information. Participants then completed autonomic, walking, and pointing assessments.

Behavioral: Neutral Movement Condition

Experimental electrodes

EXPERIMENTAL

Participants were exposed to experimental electrodes associated with verbal information suggesting discomfort, movement-evoked pain, and unpredictable electrical stimulation during movement. The transcutaneous electrical nerve stimulation device was inactive but emitted a sound to reinforce the threat manipulation. Participants then completed autonomic, walking, and pointing assessments.

Behavioral: Movement-Related Threat Induction

Interventions

Experimental induction of movement-related threat using verbal suggestions about potential discomfort and movement-evoked pain associated with electrodes placed in the lumbar region, as well as unpredictable electrical stimulation from an inactive transcutaneous electrical nerve stimulation device. The manipulation aimed to increase movement-related apprehension and anxiety during motor tasks.

Experimental electrodes

Control condition using verbal suggestions about the safety and reliability of electrodes placed in the lumbar region and associated with an inactive transcutaneous electrical nerve stimulation device. No threat-related information regarding discomfort, movement-evoked pain, or unpredictable electrical stimulation was provided. The condition aimed to assess motor and autonomic responses during motor tasks under neutral instructions.

Control electrodes

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years.
  • Ability to understand the experimental instructions and questionnaires.
  • Abstinence from short-term analgesics for 2 hours before testing.
  • Abstinence from coffee and cigarette smoking for 6 hours before testing.

You may not qualify if:

  • History of chronic pain.
  • Motor, neurological, or sensory disorders.
  • Cardiovascular conditions likely to affect physiological measurements.
  • Clinically significant depressive symptoms or anxiety scores on the Hospital Anxiety and Depression Scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurasport

Loos, 59120, France

Location

MeSH Terms

Conditions

KinesiophobiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Phobic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants underwent two conditions (control and experimental) in a randomized crossover within-subject design during a single experimental session.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 9, 2026

Study Start

November 3, 2025

Primary Completion

June 10, 2026

Study Completion

June 10, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared.

Locations