The Effect of Physiotherapy Program in Scleroderma Patients: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Scleroderma
- Sponsor
- Istanbul University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Hand Mobility in Scleroderma (HAMIS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Tugba Civi Karaaslan
Research Assistant
Istanbul University - Cerrahpasa (IUC)
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hand Mobility in Scleroderma (HAMIS)
Time Frame: before treatment, at 8 weeks, 16 weeks, and 12 months change
Hand Mobility in Scleroderma is a hand function test developed for adults who have systemic sclerosis. HAMIS consists of 9 items designed to measure all movements assessed in an ordinary range of motion-measured hand test. Each item is graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item. Each hand is assessed separately. The total score of HAMIS for each hand is 370 Sandqvist and Eklund Vol. 13, No. 6, December 2000 27, which represents a high degree of dysfunction.
Secondary Outcomes
- Semmes Weinstein Monofilaman Test(before treatment, at 8 weeks, 16 weeks, and 12 months change)
- Pittsburgh Sleep Quality Index (PSQI)(before treatment, at 8 weeks, 16 weeks, and 12 months change)
- Scleroderma Health Assessment Questionnaire (SHAQ)(before treatment, at 8 weeks, 16 weeks, and 12 months change)
- Fatigue Severity Scale (FSS)(before treatment, at 8 weeks, 16 weeks, and 12 months change)
- 9-Hole Peg Test(before treatment, at 8 weeks, 16 weeks, and 12 months change)
- Duruöz Hand Index(before treatment, at 8 weeks, 16 weeks, and 12 months change)