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The Effect of Physiotherapy Program in Scleroderma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179292
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Istanbul University-Cerrahpasa
Information provided by (Responsible Party):
Tugba Karaaslan, Istanbul University-Cerrahpasa

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.

Condition or disease Intervention/treatment Phase
Scleroderma Systemic Sclerosis Hand Rheumatism Physiotherapy Rehabilitation Other: Hand Therapy by Physiotherapist Other: Hand Therapy as home program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Physiotherapy Program in Scleroderma Patients: A Randomized Clinical Trial
Estimated Study Start Date : November 21, 2019
Estimated Primary Completion Date : November 21, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Experimental: Physiotherapy Program
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.
Other: Hand Therapy by Physiotherapist

stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total

  • 3 days / week with physiotherapist
  • 2 days / week as home program 30 minutes / day 12 repetitions
Other Name: Physiotherapy and Rehabilitation

Experimental: Home Program
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.
Other: Hand Therapy as home program

stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total

  • 3 days / week with physiotherapist
  • 2 days / week as home program 30 minutes / day 12 repetitions
Other Name: Physiotherapy and Rehabilitation




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 9-Hole Peg Test [ Time Frame: before treatment, at 8 weeks, 16 weeks, and 12 months change ]
    It is used to evaluate patients' hand and finger skills. The pegboard is placed in the middle of the body. It is desirable that 9 wooden pins be placed randomly in the 9-hole wooden block as fast as possible, and then the pins are removed from the wooden block and placed in the storage compartment one by one. These times are measured and recorded with a stopwatch. A total of 20 seconds or more is considered a "loss of skill".

  2. Duruöz Hand Index [ Time Frame: before treatment, at 8 weeks, 16 weeks, and 12 months change ]
    The Duruoz Hand Index (DHI) is a self-report questionnaire designed to evaluate activity limitations of the hand. This scale contains 18 items. Every item has a score between 0-5 and total score changes between 0-90. Higher scores indicate severe hand-related disability.

  3. Scleroderma Health Assessment Questionnaire (SHAQ) [ Time Frame: before treatment, at 8 weeks, 16 weeks, and 12 months change ]
    The Scleroderma Health Assessment Questionnaire is a measurement tool for evaluating function in individuals with systemic scleroderma and has been used in a number of countries. SHAQ is made up of 20 items distributed among eight domains and has five additional domains that assess dysfunctions caused by the symptoms of systemic scleroderma. For this, five visual analogue scales (VASs) are used. The scores on these scales are converted to subscores ranging from 0 to 3 points. The overall score of the questionnaire is the sum of each of the five VAS subscores and the scores for the eight domains, divided by 13. Lower score indicates better health status.

  4. Semmes Weinstein Monofilaman Test [ Time Frame: before treatment, at 8 weeks, 16 weeks, and 12 months change ]
    The severity of pain and paresthesia symptoms of the patients will be assessed using the 10 cm Visual Analogue Scale. Before the assessment, patients instruct that "0" for "no symptoms", "10" represents "the most severe pain that could be felt" and should mark the point that best describes the symptom. The patient's rest, activity and night pain in the last week will be questioned separately. To evaluate the paresthesia, the most severe paresthesia felt by the patient in the last 1 week will be questioned and it will be asked to mark the place that best expresses paresthesia on the scale. Marked points measure by a ruler and record in centimeters.

  5. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: before treatment, at 8 weeks, 16 weeks, and 12 months change ]
    The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

  6. Fatigue Severity Scale (FSS) [ Time Frame: before treatment, at 8 weeks, 16 weeks, and 12 months change ]
    The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179292


Contacts
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Contact: TUGBA CIVI KARAASLAN, MSc +905343855606 tugba.civi@istanbul.edu.tr

Locations
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Turkey
Tugba Civi Karaaslan Recruiting
Istanbul, Buyukcekmece, Turkey
Contact: TUGBA CIVI KARAASLAN, MSc    +905343855606    tugba.civi@istanbul.edu.tr   
Sub-Investigator: NIHAT HUSEYINSINOGLU, MSc         
Sub-Investigator: ELA TARAKCI, Assoc.Prof.         
Sponsors and Collaborators
Istanbul University
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: TUGBA CIVI KARAASLAN, MSc Research Assistant

Publications:

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Responsible Party: Tugba Karaaslan, Research Assistant, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04179292    
Other Study ID Numbers: IstanbulU2
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tugba Karaaslan, Istanbul University-Cerrahpasa:
Scleroderma
Systemic sclerosis
Hand therapy
Additional relevant MeSH terms:
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Rheumatic Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Musculoskeletal Diseases