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ACL ReconstructionKi-TASK-ACLRNCT07190456

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

A study testing Exposure to neutral images visualization, Exposure to nocive images visualisation and Exposure to anticipated realisation of a feared movement in people with ACL Reconstruction, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 2 sites in Portugal.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
ACL Reconstruction
What is being tested?
Exposure to neutral images visualization, Exposure to nocive images visualisation and Exposure to anticipated realisation of a feared movement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
2 sitesPortugal
Study dates
1 Jan 2026to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vanessa B Alpalhão, MSc contact

965844339 ext. +351

vanessaluisa@hotmail.com

Portugal2 sites, 2 recruiting
  • Egas Moniz School of Health & Science

    Almada, Monte Da Caparica, 2829-699

    João R. Vaz, PhD, 967096444 ext. +351, jvaz@egasmoniz.edu.pt

    Recruiting
  • Clínica de Fisioterapia Egas Moniz

    Caparica, Almada, 2829/511

    João R. Vaz, PhD, (+351) 21 294 68 80, jvaz@egasmoniz.edu.pt

    Vanessa B. Alpalhão, Msc, +351 965844339, vanessaluisa@hotmail.com

    Recruiting

Other trials in Portugal

About this study

Official title: Kinesiophophia or Task-specific Fear of Movement? What Are we Talking About in Patients Post Anterior Cruciate Ligament Reconstruction?

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.

Read more

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.
Being tested
Exposure to neutral images visualization, Exposure to nocive images visualisation, Exposure to anticipated realisation of a feared movement
Keywords
Motor behavior, gait complexity, Autonomic Nervous System, Heart Rate Variability, Skin Conductance
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure to neutral images visualizationOther

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

  • Exposure to nocive images visualisationOther

    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...)

  • Exposure to anticipated realisation of a feared movementOther

    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.

Study groups in NCT07190456
Study groupRoleWhat they receive
Neutral imagesSham comparatorThe patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing neutral images (landscapes, monuments...)
Receives: Other: Exposure to neutral images visualization
Nocive imagesExperimentalThe 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...)
Receives: Other: Exposure to nocive images visualisation
Antecipation feared movementExperimentalBefore 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.
Receives: Other: Exposure to anticipated realisation of a feared movement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day 0 (during intervention)

  2. 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.

    Measured: Day 0 (during intervention)

  3. 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.

    Measured: Day 0 (during intervention)

  4. 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.

    Measured: Day 0 (during intervention)

Secondary outcomes (7)
  1. Physical Function in Sports and Leisure Activities subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS-Sport/Rec)

    The KOOS is a self-reported measure that allows assessing a broad spectrum of subjects with knee injuries and OA, concerning pain and other symptoms, daily life function, sport and recreation, and knee-related quality of life. It consists of five sub-scales which are scored separately: pain (nine items); symptoms (seven items); function in ADL (17 items); Function in Sport and Recreation (five items); and Quality of Life (four items). The items are scored on a 5-point Likert scale ranging from 0 (no problems) to 4 (extreme problems). We will use the "Function in Sport and Leisure" subscale of the Portuguese version of the KOOS, for which total scores can range between 0 and 25 points, where zero represents extreme knee problems and 25 represents absence of knee problems.

    Measured: Day 0 (Before experiment)

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

    Fear-avoidance beliefs will be assessed using the Portuguese version of the FABQ. The original questionnaire was developed for subjects with chronic low back pain and consists of 16 items divided into two subscales, the FABQ-Physical Activity (FABQ-PA) and the FABQ-Work. The Portuguese version consists of 15 items, as item 8 ("I made a request for work compensation because of my pain") of the original scale was removed for being problematic. The subscale FABQ-PA of the Portuguese version consists of 5 items and the FABQ-work subscale consists of 10 items. In this study, we will use the FABQ-PA subscale specific to the knee, in which "back" will be replaced by "knee" as previously proposed in the literature. The 5 items of the FABQ-PA are scored on a 6-point Likert scale, except item 1 which is not quoted. The total score for the sub-scale can therefore range between 0 and 24 points. Higher scores on the FABQ indicate higher levels of fear-avoidance beliefs.

    Measured: Day 0 (Before experiment)

  3. Tampa Scale for Kinesiophobia 13 items version (TSK-13)

    To assess kinesiophobia, the Portuguese version of the Tampa Scale for Kinesiophobia (TSK-PT), consisting of 13 items, will be used. The individual items are scored on a 4-point Likert scale (1 to 4), where 1 corresponds to "totally disagree" and 4 corresponds to "totally agree". The total score on the scale ranges between 13 and 52, with higher scores indicating higher levels of kinesiophobia.

    Measured: Day 0 (Before experiment)

  4. Hospital Anxiety and Depression Scale (HADS)

    HADS is a screening instrument for anxiety and depression that helps to recognize the emotional components of physical illness. Structurally, it consists of two subscales, one assessing anxiety (HADS-A) and the other assessing depression (HADS-D). Each subscale contains 7 items, which are scored from 0 to 3 on a Likert scale. The total scores for each subscale range between 0 and 24 points.

    We will use the HADS-A of the Portuguese version of the scale. The HADS-A contains items 1,3,5,7,9,11 and 13 of the scale, all of which score inversely except for items 7 and 9. According to the HADS manual a score between 0 and 7 is considered "normal", between 8 and 10 indicates "mild" anxiety, between 11 and 14 "moderate" and between 15 and 21 "severe" anxiety. Other authors propose a cut-off value of 8/9 points.

    Measured: Day 0 (Before experiment)

  5. Subjective feeling of fear (SFoM)

    Numerical Rating Scale [0;100]

    Measured: 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.

  6. Avoidance behaviour related to specific feared activities

    Participants will be asked to rate their agreement on a 0 to 100 numerical rating scale, with zero representing "totally disagree" and 100 representing "totally agree", with the following statement: "Because I am afraid of pain and/or re-injury I prefer to avoid jumping"

    Measured: Day 0: after walking with visualization of feared movement and in anticipation of realizing a feared movement.

  7. Coefficient of Variation (CV)

    CV is a common linear measure that translates the amount of variability within the signal and is calculated through the standard deviation normalised to the mean from each time series (stride time and stride length).

    Measured: Day 0 (during intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start1 Jan 2026
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07190456
Sponsor's protocol ID
1476
Acronym
Ki-TASK-ACLR
Status last verified
Sep 2026
First submitted
17 Sep 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exposure to neutral images visualization, Exposure to nocive images visualisation and Exposure to anticipated realisation of a feared movement in people with ACL Reconstruction, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 2 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanessa B Alpalhão, MSc (965844339 ext. +351, vanessaluisa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fractal scaling exponent (α) (time frame: Day 0 (during intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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