Effectiveness of Telerehabilitation on Scleroderma

NCT04563481 | Unknown

• 1 other identifier: ISTANBULC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma; Scleroderma, Systemic; Scleroderma Associated Digital Ulcer; Hand Rheumatism; Physiotherapy; Rehabilitation

Keywords

Scleroderma; Systemic sclerosis; Telerehabilitation; Hand therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  change from baseline at 8 weeks

Secondary Outcomes (4)

• 9-Hole Peg Test

  change from baseline at 8 weeks

• Scleroderma Health Assessment Questionnaire (SHAQ)

  change from baseline at 8 weeks

• Semmes Weinstein Monofilaman Test

  change from baseline at 8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  change from baseline at 8 weeks

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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

Rehabilitation by Physiotherapist in the Clinic

EXPERIMENTAL

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

Interventions

Hand Therapy via Telerehabilitation OTHER

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

Telerehabilitation

Hand Therapy by Physiotherapist OTHER

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

Rehabilitation by Physiotherapist in the Clinic

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having been diagnosed with scleroderma
• Stability of medical treatments
• To be able to adapt to the exercises

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Tugba Civi Karaaslan

Istanbul, Buyukcekmece, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• TUGBA CIVI KARAASLAN, PhD (c)

  Research Assistant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TUGBA CIVI KARAASLAN, PhD (c)

CONTACT

+905343855606; tugbacivi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized Clinical Study

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 24, 2020
• Study Start: May 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 30, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)