Telerehabilitation on Hand-Affected Scleroderma

April 7, 2023 updated by: Tugba Civi Karaaslan, Istanbul University

Telerehabilitation Approach on Individuals With Hand-Affected Scleroderma

Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Buyukcekmece, Cerrahpasa Medical Faculty
      • Istanbul, Buyukcekmece, Cerrahpasa Medical Faculty, Turkey
        • Tugba Civi Karaaslan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Hand Therapy via Telerehabilitation
Experimental: Home-exercises
Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied by their own at home for 3 sessions per week.
Other: Hand Therapy via home-exercises
Hand Therapy via home-exercises
No Intervention: Control
They will have no intervention for 8 weeks. After the period, they will do home exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
change from baseline at 8 weeks
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.
change from baseline at 8 weeks
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.
change from baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: TUGBA CIVI KARAASLAN, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISTANBULC2

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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