Effectiveness of Telerehabilitation on Scleroderma

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04563481
• Other study ID #: ISTANBULC
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: Istanbul University
• Contact: TUGBA CIVI KARAASLAN, PhD (c)
• Phone: +905343855606
• Email: tugbacivi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 30, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Rheumatism
• Physiotherapy
• Rehabilitation
• Rheumatic Diseases
• Scleroderma
• Scleroderma Associated Digital Ulcer
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Tugba Civi Karaaslan	Istanbul	Buyukcekmece

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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