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Kinesiophobia After Anterior Cruciate Ligament Reconstruction.

Primary Purpose

Kinesiophobia, ACL Injury

Status
Recruiting
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
Tampa Scale of Kinesiophobia (TSK-17)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Oxford Knee Score (OKS) scoring
Quadriceps and hamstring muscle isokinetic strength
Single-leg hop test
Y-balance test
Anthropometric measurements
Sponsored by
Tartu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Kinesiophobia

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients underwent ACLR by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019. Exclusion Criteria: Patients with revision ACLR, bilateral ACLR, and postoperative infections were excluded from the study.

Sites / Locations

  • Tartu University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kinesiophobia tests

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2023
Last Updated
February 27, 2023
Sponsor
Tartu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05762809
Brief Title
Kinesiophobia After Anterior Cruciate Ligament Reconstruction.
Official Title
Kinesiophobia After Anterior Cruciate Ligament Reconstruction.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tartu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kinesiophobia, ACL Injury

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesiophobia tests
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Tampa Scale of Kinesiophobia (TSK-17)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oxford Knee Score (OKS) scoring
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quadriceps and hamstring muscle isokinetic strength
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Single-leg hop test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Y-balance test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Anthropometric measurements
Intervention Description
Body mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2.
Primary Outcome Measure Information:
Title
KOOS
Description
The primary variable of the study is the total KOOS score.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Body mass index
Description
Body mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2.
Time Frame
1 week
Title
Oxford Knee Score (OKS) scoring
Description
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.
Time Frame
1 week
Title
Tampa Scale of Kinesiophobia (TSK-17)
Description
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.
Time Frame
1 week
Title
Quadriceps and hamstring muscle isokinetic strength
Description
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.
Time Frame
1 week
Title
Single-leg hop test
Description
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.
Time Frame
1 week
Title
Y-balance test
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients underwent ACLR by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019. Exclusion Criteria: Patients with revision ACLR, bilateral ACLR, and postoperative infections were excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leho Rips, MD
Phone
5133474
Ext
+372
Email
leho.rips@kliinikum.ee
First Name & Middle Initial & Last Name or Official Title & Degree
Tauno Koovit
Phone
7319447
Ext
+372
Email
tauno.koovit@kliinikum.ee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leho Rips, MD
Organizational Affiliation
Tartu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50410
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leho Rips, MD
Phone
+3725133474
Email
leho.rips@kliinikum.ee
First Name & Middle Initial & Last Name & Degree
Tauno Koovit
Phone
+3727319447
Email
tauno.koovit@kliinikum.ee

12. IPD Sharing Statement

Plan to Share IPD
No

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Kinesiophobia After Anterior Cruciate Ligament Reconstruction.

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