Effectiveness of Telerehabilitation on Scleroderma

Investigation of the Effectiveness of Telerehabilitation on Individuals With Hand-Affected Scleroderma

The effects of exercises performed by telerehabilitation on individuals with hand-affected scleroderma on range of motion, grip strength, function, sensation, daily life activities and general health will be compared with the effects of traditional physiotherapy practices.

Study Overview

• Status: Not yet recruiting
• Conditions: Scleroderma, Systemic; Rehabilitation; Physiotherapy; Scleroderma; Hand Rheumatism; Scleroderma Associated Digital Ulcer
• Intervention / Treatment: Other: Hand Therapy by Physiotherapist; Other: Hand Therapy via Telerehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: TUGBA CIVI KARAASLAN, PhD (c); Phone Number: +905343855606; Email: tugbacivi@hotmail.com

Study Locations

• Turkey
  • Buyukcekmece
    • Istanbul, Buyukcekmece, Turkey
      • Tugba Civi Karaaslan
      • Contact: TUGBA CIVI KARAASLAN, PhD (c); Phone Number: +905343855606; Email: tugba.civi@istanbul.edu.tr
      • Sub-Investigator: Ela TARAKCI, Prof.
      • Sub-Investigator: SERDAL UGURLU, prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation; Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients via telerehabilitation for 3 sessions per week.	Other: Hand Therapy via Telerehabilitation; 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
Experimental: Rehabilitation by Physiotherapist in the Clinic; Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients by physiotherapist in the clinic for 3 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Mobility in Scleroderma (HAMIS)	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.	change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
9-Hole Peg Test	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".	change from baseline at 8 weeks
Scleroderma Health Assessment Questionnaire (SHAQ)	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.	change from baseline at 8 weeks
Semmes Weinstein Monofilaman Test	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.	change from baseline at 8 weeks
Pittsburgh Sleep Quality Index (PSQI)	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.	change from baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: TUGBA CIVI KARAASLAN, PhD (c), Research Assistant

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Telerehabilitation; Scleroderma; Systemic sclerosis; Hand therapy
• Additional Relevant MeSH Terms: Skin Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Rheumatic Diseases; Scleroderma, Localized
• Other Study ID Numbers: IstanbulC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No