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Not yet recruiting NCT07668544

Kinesiophobia and Functional Outcomes in Hand Injuries

No phase Interventional Hand Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Surgical Treatment and Routine Postoperative Care.
Who it may be relevant to
Registry conditions: Hand Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Kinesiophobia Level on Functional Outcomes in Surgically Performed Hand Injuries

Overview

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.

Interventions

  • Other Standard Surgical Treatment and Routine Postoperative Care
    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 ca

Primary outcome measures

  • Disabilities of the Arm, Shoulder and Hand (DASH) Score [Time frame: 12 weeks after injury]
Secondary outcome measures (5)
  • Hand Grip Strength [Time frame: 12 weeks after injury]
  • Buck-Gramcko Functional Score [Time frame: 8 weeks after injury]
  • Sollerman Hand Function Test Score [Time frame: 8 weeks after injury]
  • Tampa Scale of Kinesiophobia (TSK) Score [Time frame: Within 1-5 days after injury]
  • Modified Hand Injury Severity Classification (MHISC/MEYCS) Score [Time frame: Within 1-5 days after injury]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 39765429

Identifiers

NCT: NCT07668544 · MarmaraUni-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗