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Completed

NCT Number: NCT04684225

Telerehabilitation on Hand-Affected Scleroderma

Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tugba Civi Karaaslan

Istanbul, Buyukcekmece, Cerrahpasa Medical Faculty, Turkey (Türkiye)

About this study

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 home-exercises.

Firstly, the evaluation results will be published; and after all data are collected, the results will be published.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand Therapy via Telerehabilitation

Other

Hand Therapy via Telerehabilitation

Hand Therapy via home-exercises

Other

Hand Therapy via home-exercises

Primary outcomes

  1. Hand Mobility in Scleroderma (HAMIS)

    Time frame: 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 outcomes

  1. 9-Hole Peg Test

    Time frame: 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".

  2. Scleroderma Health Assessment Questionnaire (SHAQ)

    Time frame: 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.

  3. Semmes Weinstein Monofilaman Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Telerehabilitation Approach on Individuals With Hand-Affected Scleroderma

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2020
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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