Back to resultsTelerehabilitation on Hand-Affected Scleroderma
Primary Purpose
Scleroderma, Scleroderma, Systemic, Scleroderma Associated Digital Ulcer
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand Therapy via Telerehabilitation
Hand Therapy via home-exercises
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma focused on measuring Scleroderma, Systemic sclerosis, Telerehabilitation, Hand therapy
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
Sites / Locations
- Tugba Civi Karaaslan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Telerehabilitation
Home-exercises
Control
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 by their own at home for 3 sessions per week.
They will have no intervention for 8 weeks. After the period, they will do home exercises.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04684225
Brief Title
Telerehabilitation on Hand-Affected Scleroderma
Official Title
Telerehabilitation Approach on Individuals With Hand-Affected Scleroderma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma
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.
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
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
Home-exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
They will have no intervention for 8 weeks. After the period, they will do home exercises.
Intervention Type
Other
Intervention Name(s)
Hand Therapy via Telerehabilitation
Intervention Description
Hand Therapy via Telerehabilitation
Intervention Type
Other
Intervention Name(s)
Hand Therapy via home-exercises
Intervention Description
Hand Therapy via home-exercises
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUGBA CIVI KARAASLAN
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tugba Civi Karaaslan
City
Istanbul
State/Province
Buyukcekmece, Cerrahpasa Medical Faculty
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telerehabilitation on Hand-Affected Scleroderma
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