NCT06485934

Brief Summary

Questionnaires/scales used to evaluate kinesiophobia in the literature are limited and are not specific to the upper extremity in existing scales. For this reason, the primary purpose and subject of the study is to develop a multi-factor kinesiophobia scale specific to shoulder problems. The study is an observational research. Participants will be interviewed twice in total. All primary and secondary outcomes will be assessed at the first meeting. The second come will be performed within 5-7 days after the first assessment. In the second come, only the new kinesiophobia scale that is intended to be developed will be applied.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jul 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2024Jun 2026

First Submitted

Initial submission to the registry

June 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

June 27, 2024

Last Update Submit

November 18, 2025

Conditions

Keywords

KinesiophobiaShoulderDevelopment of Scale

Outcome Measures

Primary Outcomes (2)

  • Multidimensional Kinesiophobia Scale (To be developed)

    It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.

    Baseline of the study

  • Multidimensional Kinesiophobia Scale (To be developed)

    It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.

    5-7 days after baseline assessment

Secondary Outcomes (3)

  • Visual Analog Scale

    Baseline of the study

  • Tampa Kinesiophobia Scale

    Baseline of the study

  • Demographic Data Form

    Baseline of the study

Study Arms (1)

Observational Group

All of the outcomes will be applied to patients who come to the outpatient clinic due to shoulder problems. Then, 1 week later, participants will be recalled to apply the multidimensional kinesiophobia scale a second time.

Eligibility Criteria

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

Traumatological, orthopedic and rheumatological pathologies that cause fear of movement in the upper extremity

You may qualify if:

  • Tampa Kinesiophobia Score \>37 points
  • Presence of traumatological, orthopedic and rheumatological pathology in the upper extremity
  • Mini-Mental State Examination score \>24 points

You may not qualify if:

  • Malignancy,
  • Psychiatric drug use,
  • Use of painkillers during evaluation periods,
  • Those who received physiotherapy before the study (last 6 months),
  • Those whose education level is below secondary school level,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinic of İstanbul Hand-Microsurgery Rehabilitation

Istanbul, 34104, Turkey (Türkiye)

NOT YET RECRUITING

Clinic of İstanbul Hand-Microsurgery Rehabilitation

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder InjuriesKinesiophobia

Condition Hierarchy (Ancestors)

Wounds and InjuriesPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Abdurrahman Tanhan, PhD

    Bitlis Eren University

    STUDY CHAIR
  • Zeynep Hoşbay, Associate Professor

    Biruni University

    STUDY CHAIR

Central Study Contacts

Aysel Yıldız Özer, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 3, 2024

Study Start

July 22, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations