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Effectiveness of Telerehabilitation on Scleroderma

Primary Purpose

Scleroderma, Scleroderma, Systemic, Scleroderma Associated Digital Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand Therapy via Telerehabilitation
Hand Therapy by Physiotherapist
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma focused on measuring Scleroderma, Systemic sclerosis, Telerehabilitation, Hand therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tugba Civi Karaaslan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Telerehabilitation

Rehabilitation by Physiotherapist in the Clinic

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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.
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.
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.

Full Information

First Posted
September 23, 2020
Last Updated
April 12, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04563481
Brief Title
Effectiveness of Telerehabilitation on Scleroderma
Official Title
Investigation of the Effectiveness of Telerehabilitation on Individuals With Hand-Affected Scleroderma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Scleroderma, Systemic, Scleroderma Associated Digital Ulcer, Hand Rheumatism, Physiotherapy, Rehabilitation
Keywords
Scleroderma, Systemic sclerosis, Telerehabilitation, Hand therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Rehabilitation by Physiotherapist in the Clinic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hand Therapy via Telerehabilitation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Hand Therapy by Physiotherapist
Intervention Description
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
Primary Outcome Measure Information:
Title
Hand Mobility in Scleroderma (HAMIS)
Description
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.
Time Frame
change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
9-Hole Peg Test
Description
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".
Time Frame
change from baseline at 8 weeks
Title
Scleroderma Health Assessment Questionnaire (SHAQ)
Description
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.
Time Frame
change from baseline at 8 weeks
Title
Semmes Weinstein Monofilaman Test
Description
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.
Time Frame
change from baseline at 8 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
change from baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TUGBA CIVI KARAASLAN, PhD (c)
Phone
+905343855606
Email
tugbacivi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUGBA CIVI KARAASLAN, PhD (c)
Organizational Affiliation
Research Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tugba Civi Karaaslan
City
Istanbul
State/Province
Buyukcekmece
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TUGBA CIVI KARAASLAN, PhD (c)
Phone
+905343855606
Email
tugba.civi@istanbul.edu.tr
First Name & Middle Initial & Last Name & Degree
ELA TARAKCI, Prof.
First Name & Middle Initial & Last Name & Degree
SERDAL UGURLU, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Telerehabilitation on Scleroderma

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