The Effect of Physiotherapy Program in Scleroderma Patients

Istanbul University

Status: Completed

Conditions: Rehabilitation; Hand Rheumatism; Physiotherapy; Scleroderma; Systemic Sclerosis

Treatments: Other: Hand Therapy by Physiotherapist; Other: Hand Therapy as home program

Study type: Interventional

Funder types: Other

Identifiers

NCT04179292

IstanbulU2

Details and patient eligibility

About

The aim of this study was to investigate the effectiveness of physiotherapy and rehabilitation program on hand involvement of patients with scleroderma and to compare the effects of home rehabilitation program and rehabilitation program under physiotherapist supervision. At the end of the study, the rehabilitation program under the supervision of physiotherapist and home exercise program will be compared with the effects of these applications on range of motion, grip strength, function and sensation. Since there are a limited number of randomized controlled studies in the literature on this subject and there is no randomized controlled clinical study on the superiority of physiotherapist supervision and home program, it will contribute to the information regarding the rehabilitation of scleroderma patients.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having been diagnosed with scleroderma
• Stability of medical treatments
• To be able to adapt to the exercises

Exclusion criteria

• The patient has a history of neurological disease or trauma that may affect his symptoms
• Systemic involvement that affects the treatment process
• Being in the active phase of the disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Physiotherapy Program

Experimental group

Description:

Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients by physiotherapist for 3 sessions per week. On the other days, it will be implemented as an 8-week home program with 5 sessions per week.

Treatment:

Other: Hand Therapy by Physiotherapist

Home Program

Experimental group

Description:

Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients as home program. Motivation will be provided by contacting by phone / call once a week for follow-up.

Treatment:

Other: Hand Therapy as home program