Kinesiophobia After Anterior Cruciate Ligament Reconstruction.

NCT05762809 | Recruiting

• 1 other identifier: TUHST-1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Anterior cruciate ligament (ACL) rupture is a serious trauma with long-term consequences to the athlete. Psychological and physiological factors may negatively affect patient recovery and increase reinjury rate after anterior cruciate ligament reconstruction (ACLR), and development of kinesiophobia is also possible.

Conditions

Kinesiophobia; ACL Injury

Outcome Measures

Primary Outcomes (1)

• KOOS

  The primary variable of the study is the total KOOS score.

  1 week

Secondary Outcomes (6)

• Body mass index

  1 week

• Oxford Knee Score (OKS) scoring

  1 week

• Tampa Scale of Kinesiophobia (TSK-17)

  1 week

• Quadriceps and hamstring muscle isokinetic strength

  1 week

• Single-leg hop test

  1 week

Study Arms (1)

Kinesiophobia tests

EXPERIMENTAL

Patients were assessed using the Tampa Scale of Kinesiophobia (TSK-17), Knee injury and Osteoarthritis Outcome Score (KOOS), and Oxford Knee score (OKS). Ten minutes cycling with light resistance on a stationary bike was used for warm up before the physical tests. Quadriceps and hamstring muscle isokinetic strength was assessed at 60°/sec and 180°/sec using a Humac Norm Isokinetic dynamometer (Stoughton, United States). Functional performance was tested with the single-leg hop test for distance and the Y-balance test for anterior reach. The non-operated leg was tested first. All physical tests were supervised by the same specialized physiotherapists.

Diagnostic Test: Tampa Scale of Kinesiophobia (TSK-17); Diagnostic Test: Knee injury and Osteoarthritis Outcome Score (KOOS); Diagnostic Test: Oxford Knee Score (OKS) scoring; Diagnostic Test: Quadriceps and hamstring muscle isokinetic strength; Diagnostic Test: Single-leg hop test; Diagnostic Test: Y-balance test; Diagnostic Test: Anthropometric measurements

Interventions

Tampa Scale of Kinesiophobia (TSK-17) DIAGNOSTIC_TEST

The Tampa Scale of Kinesiophobia (TSK-17) was developed as a self-reported checklist to measure fear of pain during movement and fear of reinjury. The TSK-17 consists of 17 questions. Standardized answer options are given as a 4-point Likert scale, and each question is assigned a score from 1 to 4. A normalized score between 17 and 68 points is calculated. A score of 37 or over indicates kinesiophobia.

Kinesiophobia tests

Knee injury and Osteoarthritis Outcome Score (KOOS) DIAGNOSTIC_TEST

The KOOS consists of five subscales - Symptoms (S), Pain (P), Functional activities of daily living (ADL), Sport and Recreation Function (Sport/Rec) and Knee-Related Quality of life (QOL) - and total KOOS Outcome (O) scores. Standardized answer options are provided (5 Likert boxes), and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

Kinesiophobia tests

Oxford Knee Score (OKS) scoring DIAGNOSTIC_TEST

OKS consists of 12 questions. Standardized answer options are provided (5 Likert boxes), and each question is assigned a score from 0 to 4. A score of 40-48 indicates no symptoms or satisfactory joint function, 30-39 moderate knee arthritis, 20-29 moderate to severe knee arthritis, and 0-19 severe knee arthritis.

Kinesiophobia tests

Quadriceps and hamstring muscle isokinetic strength DIAGNOSTIC_TEST

Quadriceps and hamstring muscle strength at 60˚/s and 180˚/s were measured with an isokinetic dynamometer. For 180˚/s, five trial and fifteen testing repetitions were used, and for 60˚/s, three trial and three testing repetitions were used. The resting time between trial and testing was two minutes, between different speeds one minute, and between legs two minutes. The maximum peak torques were used in the statistical analysis.

Kinesiophobia tests

Single-leg hop test DIAGNOSTIC_TEST

The single-leg hop test (SLHT) for distance was used for lower limb functional testing. The test started with the participant standing on one leg, toes behind a marked line, and hands on hips throughout to avoid aiding the jump by swinging the arms. The participant was instructed to jump as far as possible and land on the same leg without losing balance. If the patient made contact with the ground with the contralateral limb, lost balance, or made additional hops after landing, the distance was not measured and the jump void. The distance was measured from the starting line to the heel of the leg being tested. For both legs, three trials and three jumps for maximal effort were allowed. The longest distance for both the left leg and the right leg were used in the statistical analysis.

Kinesiophobia tests

Y-balance test DIAGNOSTIC_TEST

The Y-balance test (YBT) (Move2Perform, United States) for anterior reach was used to measure dynamic balance. Participants performed three trials to familiarize themselves with the test, and then undertook three tests. The test started with the participant standing barefoot on the testing kit. The patients had to push a wooden box with the contralateral leg as far as possible with continuous movement and return to their starting position without losing balance. The longest distance achieved was used in the statistical analysis.

Kinesiophobia tests

Anthropometric measurements DIAGNOSTIC_TEST

Body mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2.

Kinesiophobia tests

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients underwent ACLR by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.

You may not qualify if:

• Patients with revision ACLR, bilateral ACLR, and postoperative infections were excluded from the study.

Sponsors & Collaborators

• Tartu University Hospital: lead

Study Sites (1)

Tartu University Hospital

Tartu, Tartu, 50410, Estonia

RECRUITING

Related Publications (1)

• Rips L, Koovit T, Luik M, Saar H, Kuik R, Kartus JT, Rahu M. In the medium term, more than half of males report kinesiophobia after anterior cruciate ligament reconstruction. J ISAKOS. 2024 Oct;9(5):100309. doi: 10.1016/j.jisako.2024.100309. Epub 2024 Aug 17.

  PMID: 39159822 DERIVED

MeSH Terms

Conditions

Kinesiophobia; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Leho Rips, MD

  Tartu University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leho Rips, MD

CONTACT

5133474; leho.rips@kliinikum.ee

Tauno Koovit

CONTACT

7319447; tauno.koovit@kliinikum.ee

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 10, 2023
• Study Start: March 1, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)