- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07668544
Kinesiophobia and Functional Outcomes in Hand Injuries
The Effect of Kinesiophobia Level on Functional Outcomes in Surgically Performed Hand Injuries
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Samir İlgaroğlu, Surgeon
- Número de teléfono: +905536166156
- Correo electrónico: doktorsamir.zeynal@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Minor Injury Group
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.
|
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.
Otros nombres:
|
|
Experimental: Moderate Injury Group
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.
|
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.
Otros nombres:
|
|
Experimental: Severe Injury Group
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.
|
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.
Otros nombres:
|
|
Experimental: Major Injury Group
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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Periodo de tiempo: 12 weeks after injury
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hand Grip Strength
Periodo de tiempo: 12 weeks after injury
|
Grip strength of the injured hand measured using a standard hand dynamometer.
Three measurements will be obtained and the mean value will be recorded.
|
12 weeks after injury
|
|
Buck-Gramcko Functional Score
Periodo de tiempo: 8 weeks after injury
|
Hand function, pain, and range of motion assessed using the Buck-Gramcko scoring system to evaluate intermediate-term functional recovery.
|
8 weeks after injury
|
|
Sollerman Hand Function Test Score
Periodo de tiempo: 8 weeks after injury
|
Hand function during activities of daily living assessed using the Sollerman Hand Function Test.
|
8 weeks after injury
|
|
Tampa Scale of Kinesiophobia (TSK) Score
Periodo de tiempo: Within 1-5 days after injury
|
Fear of movement and reinjury assessed using the Turkish version of the Tampa Scale of Kinesiophobia during the acute post-injury period.
|
Within 1-5 days after injury
|
|
Modified Hand Injury Severity Classification (MHISC/MEYCS) Score
Periodo de tiempo: Within 1-5 days after injury
|
Injury severity assessed using the Modified Hand Injury Severity Classification (MEYCS) at the time of initial evaluation.
|
Within 1-5 days after injury
|
Colaboradores e Investigadores
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Palabras clave
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Otros números de identificación del estudio
- MarmaraUni-01
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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