Distal Radius FractureNCT07291505
The Investigation of Kinesiophobia in Conservative Distal Radius Fractures
An observational study of Distal Radius Fracture and Kinesiophobia, run by Pamukkale University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture, Kinesiophobia, Functional Status
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 34 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 30 Dec 2026
- How long will I take part?
- 18 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Comorbid musculoskeletal-neurovascular injuries
- Bilateral injuries
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Pamukkale University
Denizli, 20170
Umut Eraslan, PhD, +905444126520, ueraslan@pau.edu.tr
- Recruiting
Pamukkale University
Denizli
Umut Eraslan, +902582964266, ueraslan@pau.edu.tr
About this study
Official title: 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.
- Conditions
- Distal Radius Fracture, Kinesiophobia, Functional Status
- Being tested
- Questionnaire and Physical Exam
- Keywords
- Tampa Scale of Kinesiophobia, distal radius fracture, wrist function, upper extremity weight bearing
- Medical subject headings
- Wrist Fractures, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated conservatively with a diagnosis of distal radius fracture | Not described Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale of Kinesiophobia
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.
Measured: At 12 and 18 weeks after injury
Goniometric measurement
Patients' forearm pronation and supination, as well as wrist flexion, extension, radial and ulnar deviation movements, will be measured using a universal goniometer.
Measured: At 12 and 18 weeks after injury
Push-Off Test
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.
Measured: At 12 and 18 weeks after injury
Patient-Rated Wrist Evaluation
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.
Measured: At 12 and 18 weeks after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start2 Feb 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
- Target duration
- 18 Weeks
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UMUT ERASLAN, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291505
- Sponsor's protocol ID
- E-60116787-020-789644
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32379119Goudie 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.
PubMed 34112544
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Predictability of Kinesiophobia on Functional Outcomes in Conservatively Treated Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT07291505
- Acronym / sponsor ID
- E-60116787-020-789644
- Conditions
- Distal Radius Fracture, Kinesiophobia, Functional Status
- Keywords
- Tampa Scale of Kinesiophobia, distal radius fracture, wrist function, upper extremity weight bearing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated conservatively with a diagnosis of distal radius fracture | – | Other: Questionnaire and Physical Exam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Comorbid musculoskeletal-neurovascular injuries
- Bilateral injuries
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 |
|---|---|---|
| Questionnaire and Physical ExamA 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. | Other | Patients treated conservatively with a diagnosis of distal radius fracture |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 32379119Jayakumar 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.
- Background: PubMed 34112544Goudie 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.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture and Kinesiophobia, run by Pamukkale University at 2 sites in Turkey (Türkiye).
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umut Eraslan, PhD (+905444126520, ueraslan@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale of Kinesiophobia (time frame: At 12 and 18 weeks after injury). The study lists 4 primary outcomes in all. 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 NCT07291505, which also lists 2 linked publications.
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 Mar 2026.