Kinesiophobia After Anterior Cruciate Ligament Reconstruction.

Not Applicable

Recruiting

• Conditions: ACL Injury; Kinesiophobia
• Interventions: 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

• Registration Number: NCT05762809
• Lead Sponsor: Tartu University Hospital

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.

Detailed Description

Anterior cruciate ligament (ACL) rupture is a serious trauma with long-term consequences to the athlete. Return to sports at the pre-injury level after anterior cruciate ligament reconstruction (ACLR) is reported between 55 and 83%. Psychological and physiological factors can negatively affect patient recovery and increase reinjury rate after ACLR. In daily practice, surgeons and physiotherapists see athletes struggling to improve muscle strength and complaining of a lack of self-confidence and fear of reinjury during their progress to return to sports.

Kinesiophobia in ACLR patients is used to determine fear of pain, lack of self-confidence, and fear of reinjury. Patients with self-reported fear are less active, have decreased muscle function, and increased risk of a second ACL injury. Lower rates of return to sports are reported in athletes with kinesiophobia after ACLR. To measure kinesiophobia, the self-reported Tampa Scale of Kinesiophobia (TSK-17) test is widely used. The original TSK was developed and described by Miller et al. in 1991. In ACLR patients, the risk of developing fear was previously measured in a large systematic review of 2175 patients, in which 514 (24%) reported a psychological reason for not returning to sports.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kinesiophobia tests	Tampa Scale of Kinesiophobia (TSK-17)	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.
Kinesiophobia tests	Quadriceps and hamstring muscle isokinetic strength	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.
Kinesiophobia tests	Y-balance test	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.
Kinesiophobia tests	Oxford Knee Score (OKS) scoring	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.
Kinesiophobia tests	Knee injury and Osteoarthritis Outcome Score (KOOS)	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.
Kinesiophobia tests	Single-leg hop test	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.
Kinesiophobia tests	Anthropometric measurements	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.

Primary Outcome Measures

Name	Time	Method
KOOS	1 week	The primary variable of the study is the total KOOS score.

Secondary Outcome Measures

Name	Time	Method
Body mass index	1 week	Body mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2.
Tampa Scale of Kinesiophobia (TSK-17)	1 week	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.
Single-leg hop test	1 week	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.
Oxford Knee Score (OKS) scoring	1 week	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.
Quadriceps and hamstring muscle isokinetic strength	1 week	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.
Y-balance test	1 week	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.

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Tartumaa, Estonia