- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07668531
Kinesiophobia and Functional Outcomes in Distal Radius Fractures
Time-Dependent Changes in Kinesiophobia and Functional Outcomes in Conservatively Treated Distal Radius Fractures
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Distal radius fractures are among the most frequently encountered upper-extremity fractures in adults and are commonly managed using conservative treatment methods, including closed reduction and cast immobilization. While successful bone healing is generally achieved, prolonged immobilization may contribute to pain, stiffness, reduced confidence in movement, and the development of kinesiophobia (fear of movement).
Kinesiophobia has been recognized as an important psychological factor that may negatively influence rehabilitation outcomes in various musculoskeletal conditions. Increased fear of movement may result in activity avoidance, delayed return to daily activities, reduced use of the affected extremity, and persistent disability. Recent studies have demonstrated associations between kinesiophobia and upper-limb functional limitations following wrist and hand injuries; however, evidence regarding the temporal evolution of kinesiophobia after conservatively treated distal radius fractures remains limited.
The primary objective of this prospective observational clinical study is to evaluate changes in kinesiophobia over time in adults with conservatively treated distal radius fractures. The secondary objective is to investigate the relationship between kinesiophobia and functional outcomes during the recovery process.
Patients aged 18-65 years with AO type A distal radius fractures treated with closed reduction and short-arm cast immobilization will be recruited from the Orthopedics and Traumatology Clinic of Marmara University Pendik Training and Research Hospital. All participants will receive standard conservative treatment. The cast will be removed at approximately five weeks after injury.
The first assessment will be performed three days after cast removal. Kinesiophobia will be evaluated using the Tampa Scale for Kinesiophobia (TSK), and pain intensity will be recorded using a Visual Analog Scale (VAS). A second assessment will be conducted at the third month following injury. At this time, kinesiophobia will be reassessed using the TSK. Functional status will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Hand and wrist function, grip strength, and relevant clinical parameters will also be assessed.
Inclusion criteria include adults aged 18-65 years with AO type A distal radius fractures treated conservatively with closed reduction and short-arm cast immobilization and without treatment-related complications. Exclusion criteria include previous fracture or neurological disorders affecting the same upper extremity, concomitant injuries involving the wrist, elbow, or shoulder, cognitive impairment, severe psychiatric disorders, and surgically treated distal radius fractures.
No experimental intervention, additional imaging procedure, or investigational medication will be used. All participants will provide written informed consent prior to enrollment. The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki.
The results of this study are expected to improve understanding of the role of kinesiophobia in recovery after distal radius fractures and may contribute to the development of rehabilitation programs targeting psychological as well as physical aspects of recovery.
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:
- 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
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Female Participants
Female adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization.
|
Standard conservative management consisting of closed reduction followed by short-arm cast immobilization for the treatment of distal radius fractures.
|
|
Experimental: Male Participants
Male adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization.
|
Standard conservative management consisting of closed reduction followed by short-arm cast immobilization for the treatment of distal radius fractures.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Kinesiophobia Level
Periodo de tiempo: Week 5 (3 days after cast removal) and Month 3
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Upper Extremity Disability
Periodo de tiempo: Month 3
|
Upper extremity disability and symptoms will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
|
Month 3
|
|
Pain Intensity
Periodo de tiempo: Week 5 and Month 3
|
Pain intensity will be assessed using a Visual Analog Scale (VAS).
|
Week 5 and Month 3
|
|
Grip Strength
Periodo de tiempo: Month 3
|
Hand grip strength will be measured using a hand dynamometer and recorded in kilograms (kg).
|
Month 3
|
|
Wrist Range of Motion
Periodo de tiempo: Month 3
|
Wrist flexion, extension, radial deviation, and ulnar deviation will be measured using a goniometer and recorded in degrees.
|
Month 3
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MarmaraUni-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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