The Effect of Physiotherapy Program in Scleroderma Patients: A Randomized Clinical Trial
Hand Therapy by Physiotherapist
+ Hand Therapy as home program
Enfermedades del Tejido Conectivo
+ Esclerodermia Sistémica
+ Enfermedades de la Piel
Estudio de Tratamiento
Resumen
Fecha de inicio: 21 de noviembre de 2019
Fecha en la que se inscribió al primer participante.Scleroderma is an autoimmune connective tissue disease with fibrosis. Although its etiology and pathogenesis have not been clearly defined, it has a chronic course. It is estimated that scleroderma affects approximately 300,000 people in the United States. Most commonly, it affects adults and women. When the current literature is examined, Landim et al. in their studies for the development and evaluation of hand exercises home program in patients with systemic scleroderma; They found that the 8-week home exercise program had positive effects on pain, function, mobility and strength. Antonioli et al. concluded that individualized rehabilitation program could improve quality of life and hand mobility in patients with systemic sclerosis. Lopes et al. found that the degree of physical disability was related to both hand grip strength and pulmonary function, but there was no relationship between hand grip strength and pulmonary function in these patients. Mancuso et al. In their case series studies examining the effect of paraffin and exercise on hand functions in scleroderma, they concluded that paraffin and hand exercises can be used to improve hand functions related to participation in daily activities. Rannou et al. in their study comparing the effects of physical therapy program and the usual care of patients with systemic sclerosis on disability, they concluded that 1-month individualized supervised physical therapy program followed by home exercise programs provided short-term benefit. Bongi et al. systemic scleroderma patients with general rehabilitation programs applied to the hand and face specific programs designed to evaluate the effectiveness of their studies; have shown that these techniques improve disability, HRQoL, hand and face functionality. A limited number of studies in the literature emphasize the need for more research with larger sample size and more variable control. The aim of this study was to investigate the effectiveness of physiotherapy and rehabilitation program on hand affected patients with scleroderma diagnosis and to compare the effects of home exercise program with physiotherapist supervision. At the end of the study, the rehabilitation program under the supervision of physiotherapist will be compared with the home exercise program and data on the effects of these applications on range of motion, grip strength, function and sensation will be obtained; their superiority to each other will be revealed.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 40 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación