- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07578883
Scar Mobilization Improves Scars and Quality of Life in Burned Children.
Effects of the Scar Tissue Mobilization on Scar Thickness, Pliability and Quality of Life in Children With Upper Extremity Burns.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Burn injuries, especially to the upper extremities, are common in children and can lead to hypertrophic scarring, resulting in pain, stiffness, and reduced range of motion. These complications significantly impact a child's ability to perform daily activities and affect overall quality of life and development. Rehabilitation plays a vital role in recovery, with scar tissue mobilization being a key intervention to improve scar flexibility and function. While commonly used, there is limited evidence on its specific effects in pediatric upper limb burns. This study aims to assess the impact of scar tissue mobilization on scar thickness, pliability and quality of life in children with upper extremity burns.
The study design will be Quasi experimental study. The data will be collected from mayo hospital, Lahore. The study will be completed in 10 months after the approval of synopsis. Children aged 8 to 13 years old will be included in this study and each patient will receive the same intervention. The participants will receive scar tissue mobilization intervention for 15 minutes twice a week for 5 weeks. Participants fulfilling the eligibility criteria will be asked to assign the consent form before entering into the study. The scar thickness and pliability will be measure from the Vancouver Scar Scale (VSS) and quality of life with Brisbane Scar Impact Profile (BBSIP). The synopsis will be presented to Research Ethical Committee of Riphah International University, Lahore for ethical approval to conduct this study. Data will be analyzed through SPSS 27.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: IMRAN AMJAD, PhD
- Número de teléfono: 9233224390125
- Correo electrónico: IMRAN.AMJAD@RIPHAH.EDU.PK
Copia de seguridad de contactos de estudio
- Nombre: Muhammad Asif Javed, MS-PT
- Número de teléfono: 9233224209422
- Correo electrónico: a.javed@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Reclutamiento
- Mayo Hospital
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Contacto:
- IMRAN AMJAD, PhD
- Número de teléfono: 9233224390125
- Correo electrónico: IMRAN.AMJAD@RIPHAH.EDU.PK
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Contacto:
- Muhammad Asif Javed, MS-PT
- Número de teléfono: 923224209422
- Correo electrónico: a.javed@riphah.edu.pk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 8-13 years
- Stable scar and referred for scar management
- Affected upper extremity joints (shoulder, elbow and wrist) with burned injuries
- Partial thickness and full thickness burn.
Exclusion Criteria:
- Pre-existing skin condition or allergies
- Neurological disorders affecting motor function
- Fracture with burn in upper limbs
- Patient with only superficial burns
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Scar Tissue Mobilization on Scars and Quality of Life in Pediatric Upper Extremity Burns
Patients received 15-minute massage sessions twice weekly for 5 weeks by the same therapist.
Techniques included moderate-pressure strokes around wounds.
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15-minute massage twice weekly for 5 weeks using baby oil by the same therapist.
Included moderate-pressure strokes, finger pressing, circular movements, skin rolling, and finishing gliding strokes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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vancouver scar scale
Periodo de tiempo: Baseline, 5 week
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The Vancouver Scar Scale (VSS) is a widely used semi-quantitative tool for scar assessment that evaluates four parameters: vascularity, pigmentation, pliability, and height/thickness.
It has a total score range of 0-13/14, where 0 indicates normal skin and higher scores represent more severe scarring, including thick scars and contractures.
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Baseline, 5 week
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Brisbane burn scar impact profile (BBSIP)
Periodo de tiempo: Baseline, 5 week
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A 40-item scale assessing children's quality of life across domains such as daily activities, hand function, appearance, psychological status, social relationships, and school activities.
Items are scored from 0 (not at all) to 4 (a lot), with total scores classified as good (40-80), fair (80-100), and poor (>100).
A 58-item burn scar-specific HRQoL self-report tool covering 10 domains including sensory, mobility, daily living, social interaction, appearance, and emotional reactions.
Items use dichotomous, 11-point, or 5-point Likert scales; scores are calculated per domain, with lower scores indicating better quality of life.
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Baseline, 5 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Areej Saher, MS-PT, Riphah International University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- REC/RCR&AHS/24/Areej Saher
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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