Effectiveness of Telerehabilitation on Scleroderma

Sponsor

Istanbul University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04563481

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Scleroderma Scleroderma, Systemic Scleroderma Associated Digital Ulcer Hand Rheumatism Physiotherapy Rehabilitation	Other: Hand Therapy via Telerehabilitation Other: Hand Therapy by Physiotherapist	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Clinical StudyRandomized Clinical Study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Investigation of the Effectiveness of Telerehabilitation on Individuals With Hand-Affected Scleroderma

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

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 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
Experimental: Rehabilitation by Physiotherapist in the Clinic 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.	Other: Hand Therapy by Physiotherapist 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

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

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

Experimental: Rehabilitation by Physiotherapist in the Clinic

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.

Other: Hand Therapy by Physiotherapist

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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