NCT07668531

Brief Summary

Distal radius fractures are among the most common fractures in adults and are frequently treated with closed reduction and cast immobilization. Although fracture healing is generally successful, some patients may develop fear of movement (kinesiophobia) after cast removal because of pain, reinjury concerns, or reduced confidence in using the injured wrist. The purpose of this study is to evaluate the level of kinesiophobia in adults with conservatively treated distal radius fractures and to investigate how kinesiophobia changes over time following cast removal. The study will also examine the relationship between kinesiophobia and functional recovery. Participants will be assessed after cast removal and again at three months following injury. Kinesiophobia, pain intensity, hand and wrist function, range of motion, grip strength, and upper extremity disability will be evaluated using standardized assessment tools. The findings may help clinicians better understand the role of movement-related fear in recovery and support the development of rehabilitation strategies aimed at improving functional outcomes after distal radius fractures.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress7%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

June 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

July 19, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2027

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2027

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 19, 2026

Last Update Submit

June 19, 2026

Conditions

Distal Radius Fracture

Keywords

KinesiophobiaFunctional Recovery

Outcome Measures

Primary Outcomes (1)

  • Change in Kinesiophobia Level

    Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK). Changes in TSK scores between the assessment performed 3 days after cast removal (approximately week 5) and the assessment performed at month 3 will be evaluated.

    Week 5 (3 days after cast removal) and Month 3

Secondary Outcomes (4)

  • Upper Extremity Disability

    Month 3

  • Pain Intensity

    Week 5 and Month 3

  • Grip Strength

    Month 3

  • Wrist Range of Motion

    Month 3

Study Arms (2)

Female Participants

EXPERIMENTAL

Female adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization.

Other: Conservative Treatment of Distal Radius Fracture

Male Participants

EXPERIMENTAL

Male adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization.

Other: Conservative Treatment of Distal Radius Fracture

Interventions

Conservative Treatment of Distal Radius FractureOTHER

Standard conservative management consisting of closed reduction followed by short-arm cast immobilization for the treatment of distal radius fractures.

Female ParticipantsMale Participants

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range: 18-65 years
  • Non-intra-articular extension (AO type A) distal radius fracture
  • Treatment with closed reduction and short arm cast
  • No complications during treatment (redisplacement, fracture failure, etc.)
  • Ability to cooperate and complete the questionnaire

You may not qualify if:

  • History of previous fracture or neurological pathology in the same extremity
  • Associated wrist, elbow, or shoulder injury
  • Cognitive impairment or serious psychiatric illness
  • Surgically treated distal radius fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Roman-Veas J, Gutierrez-Monclus R, Lopez-Gil JF, Valenzuela-Fuenzalida J, Araya-Quintanilla F, Gutierrez-Espinoza H, Hagert E. Baseline predictors related to functional outcomes in patients older than sixty years with complex regional pain syndrome type 1 after distal radius fracture treated conservatively: a prospective observational study. Int Orthop. 2023 Sep;47(9):2275-2284. doi: 10.1007/s00264-023-05880-0. Epub 2023 Jul 13.

    PMID: 37438487BACKGROUND

MeSH Terms

Conditions

Wrist FracturesKinesiophobia

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BonePhobic DisordersAnxiety DisordersMental Disorders

Central Study Contacts

Samir İlgaroğlu, Surgeon

CONTACT

+905536166156doktorsamir.zeynal@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 25, 2026

Study Start

July 19, 2026

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

February 5, 2027

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share