NCT07668544

Brief Summary

Hand and forearm injuries are among the most common traumatic injuries and may result in substantial functional limitations, reduced work capacity, and decreased quality of life. Despite advances in surgical repair techniques, recovery outcomes vary considerably among individuals with similar injury characteristics. Psychological factors, particularly fear of movement or reinjury (kinesiophobia), may influence rehabilitation participation and functional recovery after injury. The aim of this prospective observational study is to investigate the relationship between early kinesiophobia levels and functional outcomes in adults who undergo surgical treatment for traumatic hand or forearm lacerations. Kinesiophobia will be assessed during the acute post-injury period (within 1-5 days after injury) using the Tampa Scale of Kinesiophobia. Injury severity will be evaluated using the Modified Hand Injury Severity Classification (MHISC/MEYCS). Participants will be followed for 12 weeks after injury. Functional recovery will be assessed at the 8th week using the Buck-Gramcko Score and the Sollerman Hand Function Test, and at the 12th week using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and hand grip strength measurements. The study will examine whether higher levels of early kinesiophobia are associated with greater injury severity and poorer functional recovery. Findings from this study may help identify patients at risk for delayed recovery and support the development of early rehabilitation strategies targeting psychological as well as physical aspects of hand injury recovery.

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
8mo left

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2026Mar 2027

First Submitted

Initial submission to the registry

June 19, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 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

Keywords

kinesiophobiafunctionality

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand (DASH) Score

    Functional disability and symptoms of the upper extremity assessed using the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The study will evaluate the association between early kinesiophobia levels measured within 1-5 days after injury and functional outcomes at 12 weeks following surgically treated hand and forearm injuries.

    12 weeks after injury

Secondary Outcomes (5)

  • Hand Grip Strength

    12 weeks after injury

  • Buck-Gramcko Functional Score

    8 weeks after injury

  • Sollerman Hand Function Test Score

    8 weeks after injury

  • Tampa Scale of Kinesiophobia (TSK) Score

    Within 1-5 days after injury

  • Modified Hand Injury Severity Classification (MHISC/MEYCS) Score

    Within 1-5 days after injury

Study Arms (4)

Minor Injury Group

EXPERIMENTAL

Participants with traumatic hand or forearm injuries classified as minor according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS \<20). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes.

Other: Standard Surgical Treatment and Routine Postoperative Care

Moderate Injury Group

EXPERIMENTAL

Participants with traumatic hand or forearm injuries classified as moderate according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS 21-50). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes.

Other: Standard Surgical Treatment and Routine Postoperative Care

Severe Injury Group

EXPERIMENTAL

Participants with traumatic hand or forearm injuries classified as severe according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS 51-100). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes.

Other: Standard Surgical Treatment and Routine Postoperative Care

Major Injury Group

EXPERIMENTAL

Participants with traumatic hand or forearm injuries classified as major according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS \>101). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes.

Other: Standard Surgical Treatment and Routine Postoperative Care

Interventions

Participants with traumatic hand or forearm injuries will receive surgical treatment and postoperative management according to routine clinical practice and the treating surgeon's decision. No experimental treatment, device, medication, or rehabilitation protocol will be administered as part of the study. The study is observational in nature and aims to evaluate the relationship between early kinesiophobia levels, injury severity, and subsequent functional outcomes following standard surgical care.

Also known as: Routine Clinical Management
Major Injury GroupMinor Injury GroupModerate Injury GroupSevere Injury Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years and older. Patients presenting to the emergency department with traumatic hand or forearm lacerations requiring surgical treatment.
  • Injury involving one or more anatomical structures of the hand or forearm (skin, tendon, nerve, vessel, or combined injuries).
  • Assessment within 1-5 days following injury. Ability to understand and complete study questionnaires and functional assessments.
  • Provision of written informed consent. Willingness to participate in follow-up assessments at 8 and 12 weeks after injury.

You may not qualify if:

  • Age younger than 18 years. Cognitive impairment, severe psychiatric disorder, or communication problems preventing completion of questionnaires.
  • Previous major injury, surgery, or permanent functional impairment of the affected upper extremity.
  • Polytrauma or additional injuries that may substantially affect upper extremity function or rehabilitation outcomes.
  • Neurological disorders affecting upper extremity function (e.g., stroke, peripheral neuropathy, spinal cord injury).
  • Severe musculoskeletal disorders of the upper extremity unrelated to the index injury.
  • Inability or unwillingness to attend follow-up evaluations. Refusal to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cantero-Tellez R, Rider J, Cruz-Gambero L, Villafane JH, Valdes K. Kinesiophobia, catastrophizing, and the duration of immobilization: A prospective study on factors associated with shoulder disability following wrist-hand injuries. J Hand Ther. 2025 Jul-Sep;38(3):477-482. doi: 10.1016/j.jht.2024.08.004. Epub 2025 Jan 6.

    PMID: 39765429BACKGROUND

MeSH Terms

Conditions

Hand InjuriesKinesiophobia

Condition Hierarchy (Ancestors)

Wounds and InjuriesPhobic DisordersAnxiety DisordersMental Disorders

Central Study Contacts

Samir İlgaroğlu, Surgeon

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
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

June 19, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

March 17, 2027

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share