Effectiveness of Telerehabilitation on Scleroderma

Not Applicable

• Conditions: Scleroderma; Scleroderma, Systemic; Hand Rheumatism; Physiotherapy; Scleroderma Associated Digital Ulcer; Rehabilitation
• Interventions: Other: Hand Therapy by Physiotherapist; Other: Hand Therapy via Telerehabilitation

• Registration Number: NCT04563481
• Lead Sponsor: Istanbul University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13
• Study Start: 2022-05-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation by Physiotherapist in the Clinic	Hand Therapy by Physiotherapist	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.
Telerehabilitation	Hand Therapy via 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.

Primary Outcome Measures

Name	Time	Method
Hand Mobility in Scleroderma (HAMIS)	change from baseline at 8 weeks	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

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

Trial Locations

Locations (1)

Tugba Civi Karaaslan; 🇹🇷 Istanbul, Buyukcekmece, Turkey