NCT07291505

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Feb 2026

Shorter than P25 for all trials

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 Progress29%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

December 5, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

Tampa Scale of Kinesiophobiadistal radius fracturewrist functionupper extremity weight bearing

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    At 12 and 18 weeks after injury

Study Arms (1)

Patients treated conservatively with a diagnosis of distal radius fracture

Other: Questionnaire and Physical Exam

Interventions

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.

Patients treated conservatively with a diagnosis of distal radius fracture

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Comorbid musculoskeletal-neurovascular injuries
  • Bilateral injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pamukkale University

Denizli, 20170, Turkey (Türkiye)

NOT YET RECRUITING

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32379119BACKGROUND
  • 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.

    PMID: 34112544BACKGROUND

MeSH Terms

Conditions

Wrist FracturesKinesiophobia

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BonePhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Central Study Contacts

Umut Eraslan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

February 2, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations