Kinesiophobia vs. Task-Specific Fear: Defining Movement-Related Fear in ACL Reconstruction Patients

NCT07190456 | Recruiting

• 1 other identifier: 1476
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

Kinesiophobia, defined as an excessive and irrational fear of physical movement due to perceived vulnerability to injury, has gained significant attention in clinical and scientific communities. This condition can act as a barrier to physical activity, negatively impacting patients' disability, quality of life, and the implementation of rehabilitation programs. It is particularly prevalent after anterior cruciate ligament reconstruction (ACLR), affecting physical function, return to sport rates, and patient performance. While the Tampa Scale for Kinesiophobia (TSK) is considered a gold standard for assessing kinesiophobia, recent studies have raised concerns about its validity, especially in ACLR patients. The TSK may not adequately capture fear of specific sports activities, which is more common in ACLR patients than a general phobia of movement. Some researchers argue for an assessment approach similar to that used for pain experiences, emphasizing the subjective nature of fear. Based on the specific phobia model, assessing kinesiophobia in the presence of a trigger, such as visualizing or confronting the movement associated with the injury, may be more relevant. This approach is supported by evidence showing that sports situations evoking the greatest fear after ACLR are cutting, jumping, and contact. Further research is needed to investigate alternative methodologies for assessing fear of movement in ACLR patients, considering the prevalence and repercussions of kinesiophobia in this population. The objectives of this study are threefold:

• To compare the magnitude of kinesiophobia through the TSK, the subjective feeling of fear when visualising feared movements, and the subjective feeling of fear in anticipation of the feared situation.
• Evaluate the impact of focusing on feared activities on motor behavior and Autonomic Nervous System (ANS) markers.
• To assess the relation between the three methods of assessing fear of movement and indicators of motor behaviour, ANS activity, fear-avoidance beliefs, anxiety, avoidance behaviour, and physical function.

Conditions

ACL Reconstruction

Keywords

Motor behavior; gait complexity; Autonomic Nervous System; Heart Rate Variability; Skin Conductance

Outcome Measures

Primary Outcomes (4)

• Fractal scaling exponent (α)

  The fractal scaling exponent quantifies the complexity of a physiological signal and detects the presence of statistical persistence in a given time series. This parameter is calculated using Detrended Fluctuation Analysis (DFA) from each time series (stride time and stride length).

  Day 0 (during intervention)

• Heart rate variability

  The R-R intervals will be derived from beat-to-beat blood pressure pulse intervals using finger plethysmography (Finapres® Nova, Amsterdam, Netherlands), at rest and during the gait trials. Finger plethysmography-derived peak-to-peak intervals are highly correlated with ECG R-R intervals, with similar variability. The upstroke is determined using the pressure signal with a resolution of 2 ms, and the interval between the two consecutive upstrokes is measured. In the frequency domain, the two primary components are low-frequency (LF; 0.04-0.15 Hz) and high-frequency (HF; 0.15-0.40 Hz) spectra. Heart rate variability measures provide information primarily on vagal modulation with the LF power spectrum reflecting both sympathetic and parasympathetic modulation and HF acting as a surrogate marker of parasympathetic modulation of the R-R intervals. The LF/HF ratio is used to indicate sympathovagal dominance.

  Day 0 (during intervention)

• Skin conductance

  The skin conductance response (SCR) of the patients will be measured while they are exposed to the stimuli of the three experimental conditions. The SCR is an indicator of physiological arousal and is measured by detecting changes in the electrical conductance of the skin, which varies with the activity of the sweat glands. This assessment aims to understand the response of the patient's autonomic nervous system to the experimental conditions.

  Day 0 (during intervention)

• Blood pressure variability

  Systolic and diastolic blood pressure values will be derived from beat-to-beat blood pressure recordings using finger plethysmography during all gait trials. Finger plethysmography-derived systolic and diastolic blood pressure signals are recorded with high precision and beat-to-beat variability in blood pressure is calculated with a resolution of 2 ms. The variability is assessed by measuring the intervals between consecutive systolic upstrokes in the blood pressure waveform. BPV is analyzed by decomposing the signal into two primary components: low-frequency (LF; 0.04-0.15 Hz) and high-frequency (HF; 0.15-0.40 Hz) spectra. Blood pressure variability in the LF range reflects sympathetic modulation of vascular tone and arterial baroreflex sensitivity, while HF variability is often associated with respiratory influences and parasympathetic activity. The LF/HF ratio is used as an indicator of the balance between sympathetic and parasympathetic contributions to blood pressure regulation.

  Day 0 (during intervention)

Secondary Outcomes (7)

• Physical Function in Sports and Leisure Activities subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS-Sport/Rec)

  Day 0 (Before experiment)

• Physical Activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ-PA)

  Day 0 (Before experiment)

• Tampa Scale for Kinesiophobia 13 items version (TSK-13)

  Day 0 (Before experiment)

• Hospital Anxiety and Depression Scale (HADS)

  Day 0 (Before experiment)

• Subjective feeling of fear (SFoM)

  Day 0 : After walking with visualization of neutral images; after walking with visualization of feared movements; after walking with visualization of feared movement and in the anticipation of realizing a feared movement.

Other Outcomes (1)

• Subjective level of immersion

  Day 0: At the end of the experimental conditions

Study Arms (3)

Neutral images

SHAM COMPARATOR

The patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing neutral images (landscapes, monuments...)

Other: Exposure to neutral images visualization

Nocive images

EXPERIMENTAL

The patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing images interpreted as nocive (cutting, jumping, contact...)

Other: Exposure to nocive images visualisation

Antecipation feared movement

EXPERIMENTAL

Before the start of the experimental condition, the patient will be asked to think about their willingness to perform the first movement visualised in the video, while a researcher places a jumping platform inside the laboratory. During the test, the patient will have to walk on a treadmill at their preferred speed for 10 minutes, while watching a video showing a drop jump followed by images interpreted as nocive for the rest of the time.

Other: Exposure to anticipated realisation of a feared movement

Interventions

Exposure to neutral images visualization OTHER

The patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing neutral images (landscapes, monuments...)

Neutral images

Exposure to nocive images visualisation OTHER

The patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing images interpreted as nocive (cutting, jumping, contact...)

Nocive images

Exposure to anticipated realisation of a feared movement OTHER

Before the start of the experimental condition, the patient will be asked to think about their willingness to perform the first movement visualised in the video, while a researcher places a jumping platform inside the laboratory. During the test, the patient will have to walk on a treadmill at their preferred speed for 10 minutes, while watching a video showing a drop jump followed by images interpreted as nocive for the rest of the time.

Antecipation feared movement

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient must have given their informed consent and signed the consent form.
• The patient must have enough comprehension of the Portuguese language to complete the written questionnaires.
• The patient must have suffered an ACL injury, with or without a history of concomitant meniscal pathology, while playing or training for sport (recreational or organized).
• The patient must have undergone anterior cruciate ligament reconstruction surgery.
• The patient must be between 18 and 35 years old.
• The patient must still be under medical care/rehabilitation due to the ACL injury.
• The patient must have started jump landing tasks.

You may not qualify if:

• The subject has a history of repeated ACLR.
• The subject has not injured the ACL while playing sports.
• The subject presents a concurrent psychiatric disorder
• The subject has a history of heart disease and/or peripheral vascular disease and/or metabolic disease and/or Raynaud´s Syndrome.
• The subject is taking any medications known to affect heart rate or blood pressure
• The subject is currently a smoker.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (2)

Clínica de Fisioterapia Egas Moniz

Caparica, Almada, 2829/511, Portugal

RECRUITING

Egas Moniz School of Health & Science

Almada, Monte Da Caparica, 2829-699, Portugal

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Vanessa B Alpalhão, MSc

CONTACT

965844339; vanessaluisa@hotmail.com

João R. Vaz, PhD

CONTACT

967096444; jvaz@egasmoniz.edu.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)