- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07665541
TASK-ORIENTED REHABILITATION AFTER ROTATOR CUFF SURGERY
THE EFFECT OF TASK-ORIENTED OCCUPATIONAL THERAPY INTERVENTION ON ACTIVITY PARTICIPATION AFTER ROTATOR CUFF SURGERY: PRE- AND POST-INTERVENTION EVALUATION
Rotator cuff tears negatively affect shoulder stability, range of motion, and performance in daily activities. Postoperative rehabilitation is essential for improving functional recovery and quality of life; however, conventional approaches may not directly target meaningful activity performance.
Task-oriented occupational therapy is a client-centered approach focusing on meaningful and goal-directed activities to enhance functional independence. This randomized controlled trial aims to investigate the effect of task-oriented occupational therapy on activity participation, occupational performance, satisfaction, and functional recovery after rotator cuff surgery.
A total of 30 participants will be randomly assigned to either a task-oriented occupational therapy group or a conventional rehabilitation group. The intervention will be conducted twice weekly for 10 weeks, with 40-minute sessions based on individually prioritized activities identified using the Canadian Occupational Performance Measure. Outcomes will include occupational performance and satisfaction, goal attainment, shoulder function, quality of life, and patient satisfaction.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34815
- Istanbul Medipol University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Individuals aged 18 years and older
- Individuals who have undergone rotator cuff surgery
- Medically stable and cleared for participation in a rehabilitation program
- Ability to understand and follow instructions
- Voluntary agreement to participate in the study
Exclusion Criteria:
- - Presence of severe neurological disorders affecting upper extremity function
- Severe cognitive impairment limiting participation
- Additional musculoskeletal conditions affecting the upper extremity
- Postoperative complications that may interfere with rehabilitation
- Participation in another rehabilitation program during the study period
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 |
|---|---|
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Experimental: Task-oriented intervention group
In this group patient who have undergone rototor cuff surgery will receive a task oriented exercise program based on activities off daily living conducted twice a week for ten weeks.
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In this intervention, following rotator cuff surgery, task-oriented occupational therapy sessions based on activities of daily living will be applied.
These sessions will be conducted twice a week for 10 weeks and aim to achieve improvements in participants' activity performance and activity satisfaction.
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Comparador activo: Conventional rehabilitation group
Participants included in the conventional intervention group will continue with the standard rehabilitation program applied in the postoperative period.
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This intervention includes exercises aimed at improving joint range of motion, enhancing muscle strength, and supporting muscle flexibility.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occupational performance and satisfaction measured by the Canadian Occupational Performance Measure (COPM)
Periodo de tiempo: Baseline and after 10 weeks of intervention
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Occupational performance and satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM).
The change in COPM performance and satisfaction scores from baseline to post-intervention will be evaluated.
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Baseline and after 10 weeks of intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- E-10840098-202.3.02-8555
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .