NCT06336200

Brief Summary

Kinesiophobia after total knee arthroplasty is an important parameter affecting recovery. However, the relationship between kinesiophobia and the factors it may cause is not clear. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

March 22, 2024

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Kinesiophobia

    Tampa Kinesiophobia Scale will be used to measure the level of fear of movement and re-injury. In this scale, a score ranges from 17 to 68, and an increase in the score means an increase in kinesiophobia. A score of 39.5 and above indicates the presence of high kinesiophobia.

    Baseline

  • Severity of pain

    Visual analog scale (VAS) will be used to evaluate individuals' level of knee pain. A value of 0 indicates no pain, a value of 10 indicates very high pain.

    Baseline

  • Functional mobility

    'Timed Up and Go Test' will be used to evaluate the mobility and functions of the patients.

    Baseline

  • Proprioception

    Patients' knee joint proprioception sense will be measured with the 'Knee Joint Position Sense Test'. The angle of deviation from the target angle will be determined.

    Baseline

  • Fear of falling

    While performing daily living activities, self-confidence and fear of falling will be evaluated with The Falls Efficacy Scale-International. A score between 16-65 is taken and as the total score increases, the probability of falling increases.

    Baseline

Study Arms (2)

Higher Kinesiophobia

It is a group with a high level of kinesiophobia according to the "Tampa kinesiophobia scale".

Lower Kinesiophobia

It is a group with a low level of kinesiophobia according to the "Tampa kinesiophobia scale".

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals who have undergone total knee arthroplasty surgery will be included in the study. Patients will be divided into two groups, high and low kinesiophobia levels, according to the Tampa Kinesiophobia Scale.

You may qualify if:

  • Being between the ages of 18-80
  • Total knee arthroplasty surgery due to knee osteoarthritis
  • Volunteering to participate in the study

You may not qualify if:

  • Previously had knee surgery or fracture
  • Diagnosed with rheumatoid arthritis
  • Those with severe obesity (BMI \> 40 kg/m2)
  • Those with sensory and motor impairments
  • Revision knee arthroplasty planned
  • Venous thromboembolism
  • Neurological diseases (MS, Parkinson, etc.)
  • Early post-surgical complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Pursaklar Public Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeKinesiophobia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 28, 2024

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

November 13, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations