KinesiophobiaNCT05762809
Kinesiophobia After Anterior Cruciate Ligament Reconstruction.
A study testing Tampa Scale of Kinesiophobia (TSK-17), Knee injury and Osteoarthritis Outcome Score (KOOS) and Oxford Knee Score (OKS) scoring in people with Kinesiophobia and ACL Injury, run by Tartu University Hospital at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Kinesiophobia, ACL Injury
- What is being tested?
- Tampa Scale of Kinesiophobia (TSK-17), Knee injury and Osteoarthritis Outcome Score (KOOS) and Oxford Knee Score (OKS) scoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Mar 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients underwent ACLR by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.
Who cannot join
- Patients with revision ACLR, bilateral ACLR, and postoperative infections were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, Tartu, 50410
Leho Rips, MD, +3725133474, leho.rips@kliinikum.ee
Tauno Koovit, +3727319447, tauno.koovit@kliinikum.ee
About this study
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.
Read the 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.
- Conditions
- Kinesiophobia, ACL Injury
- Being tested
- 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
- Medical subject headings
- Kinesiophobia, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Oxford Knee Score (OKS) scoringDiagnostic 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.
Quadriceps and hamstring muscle isokinetic strengthDiagnostic 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.
Single-leg hop testDiagnostic 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 testDiagnostic 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.
Anthropometric measurementsDiagnostic test
Body mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS
The primary variable of the study is the total KOOS score.
Measured: 1 week
Secondary outcomes (6)
Body mass index
Body mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Mar 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leho Rips, MD, Principal investigator, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762809
- Sponsor's protocol ID
- TUHST-1
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39159822
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia After Anterior Cruciate Ligament Reconstruction.
- ClinicalTrials.gov ID
- NCT05762809
- Acronym / sponsor ID
- TUHST-1
- Conditions
- Kinesiophobia, ACL Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinesiophobia tests | Experimental | 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 measurementsPatients 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. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients underwent ACLR by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.
Key exclusion criteria (1 listed)
- Patients with revision ACLR, bilateral ACLR, and postoperative infections were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Kinesiophobia tests |
| Knee injury and Osteoarthritis Outcome Score (KOOS)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. | Diagnostic test | Kinesiophobia tests |
| Oxford Knee Score (OKS) scoringOKS 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. | Diagnostic test | Kinesiophobia tests |
| Quadriceps and hamstring muscle isokinetic strengthQuadriceps 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. | Diagnostic test | Kinesiophobia tests |
| Single-leg hop testThe 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. | Diagnostic test | Kinesiophobia tests |
| Y-balance testThe 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. | Diagnostic test | Kinesiophobia tests |
| Anthropometric measurementsBody mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2. | Diagnostic test | Kinesiophobia tests |
Primary outcome
KOOS
Time frame: 1 week
The primary variable of the study is the total KOOS score.
6 secondary outcomes
Body mass index
Time frame: 1 week
Oxford Knee Score (OKS) scoring
Time frame: 1 week
Tampa Scale of Kinesiophobia (TSK-17)
Time frame: 1 week
Quadriceps and hamstring muscle isokinetic strength
Time frame: 1 week
Single-leg hop test
Time frame: 1 week
Y-balance test
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 39159822Rips 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leho Rips, MD principal investigator
Tartu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tampa Scale of Kinesiophobia (TSK-17), Knee injury and Osteoarthritis Outcome Score (KOOS) and Oxford Knee Score (OKS) scoring in people with Kinesiophobia and ACL Injury, run by Tartu University Hospital at 1 site in Estonia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leho Rips, MD (5133474 ext. +372, leho.rips@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762809, which also lists 1 linked publication.
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 Apr 2024.