- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291505
The Investigation of Kinesiophobia in Conservative Distal Radius Fractures
March 9, 2026 updated by: UMUT ERASLAN, Pamukkale University
Investigation of the Predictability of Kinesiophobia on Functional Outcomes in Conservatively Treated Distal Radius Fractures
This study aimed to investigate the predictability of kinesiophobia on functional outcomes in conservatively treated patients with distal radius fractures.
For this purpose, patients' level of kinesiophobia will be assessed using the Tampa Kinesiophobia Scale.
To assess the functional status of patients, joint range of motion and upper extremity weight bearing measurements will be performed.
Patients' functionality will be additionally assessed with the Patient Rated Wrist Evaluation Questionnaire.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
34
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Umut Eraslan, PhD
- Phone Number: +905444126520
- Email: ueraslan@pau.edu.tr
Study Locations
-
-
-
Denizli, Turkey (Türkiye)
- Recruiting
- Pamukkale University
-
Contact:
- Umut Eraslan
- Phone Number: +902582964266
- Email: ueraslan@pau.edu.tr
-
Denizli, Turkey (Türkiye), 20170
- Not yet recruiting
- Pamukkale University
-
Contact:
- Umut Eraslan, PhD
- Phone Number: +905444126520
- Email: ueraslan@pau.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Volunteers among the patients who were referred to the hand rehabilitation unit after being followed conservatively with a diagnosis of distal radius fracture in the hand surgery clinic of a university hospital will be included in the study.
Description
Inclusion Criteria:
- Having been treated conservatively with an isolated distal radius fracture diagnosis,
- Having a cognitive level that allows one to understand assessment methods and apply instructions.
Exclusion Criteria:
- Comorbid musculoskeletal-neurovascular injuries
- Bilateral injuries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients treated conservatively with a diagnosis of distal radius fracture
|
A goniometric assessment will be performed to measure the range of motion in the wrist-forearm joint, and a Push Off test will be conducted to measure the upper extremity weight-bearing capacity. Additionally, the Tampa Scale of Kinesiophobia and Patient-Rated Wrist Evaluation Questionnaire will be administered to patients using a face-to-face assessment method. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale of Kinesiophobia
Time Frame: At 12 and 18 weeks after injury
|
It is a 17-item scale scored using a 4-point Likert scale (1 = Strongly disagree, 4 = Strongly agree).
A total score is calculated after reversing items 4, 8, 12, and 16.
The individual receives a total score between 17 and 68.
A high score on the scale indicates a high level of kinesiophobia.
|
At 12 and 18 weeks after injury
|
|
Goniometric measurement
Time Frame: At 12 and 18 weeks after injury
|
Patients' forearm pronation and supination, as well as wrist flexion, extension, radial and ulnar deviation movements, will be measured using a universal goniometer.
|
At 12 and 18 weeks after injury
|
|
Push-Off Test
Time Frame: At 12 and 18 weeks after injury
|
It determines the force that the person can exert on their injured limb.
The measurement will be taken using a Jamar hand dynamometer.
While the person is standing, with the shoulder at 30 degrees of extension and the elbow at 30 degrees of flexion, the measurement will be repeated three times and the average recorded in kilograms.
|
At 12 and 18 weeks after injury
|
|
Patient-Rated Wrist Evaluation
Time Frame: At 12 and 18 weeks after injury
|
It measures the severity of wrist pain and the level of disability in activities of daily living.
The survey consists of two subsections with a total of 15 questions.
Each question is answered on a scale of 0 to 10 (0 = no pain/difficulty; 10 = maximum pain felt/inability to perform).
The scores for the pain and function sections are added together to determine the final score, which is calculated out of 100.
A high score indicates a high level of pain and disability.
|
At 12 and 18 weeks after injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jayakumar P, Teunis T, Vranceanu AM, Lamb S, Ring D, Gwilym S. Early Psychological and Social Factors Explain the Recovery Trajectory After Distal Radial Fracture. J Bone Joint Surg Am. 2020 May 6;102(9):788-795. doi: 10.2106/JBJS.19.00100.
- Goudie ST, Broll R, Warwick C, Dixon D, Ring D, McQueen M. The Association Between Psychological Factors and Outcomes After Distal Radius Fracture. J Hand Surg Am. 2022 Feb;47(2):190.e1-190.e10. doi: 10.1016/j.jhsa.2021.04.012. Epub 2021 Jun 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
December 5, 2025
First Submitted That Met QC Criteria
December 17, 2025
First Posted (Actual)
December 18, 2025
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Wounds and Injuries
- Fractures, Bone
- Arm Injuries
- Phobic Disorders
- Anxiety Disorders
- Wrist Injuries
- Wrist Fractures
- Kinesiophobia
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Therapeutics
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Behavior Control
- Immobilization
- Surveys and Questionnaires
- Restraint, Physical
Other Study ID Numbers
- E-60116787-020-789644
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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